1. No category

Version: 27 March 2013
page 1 of 4
PART I CML
REGISTRATION AND DIAGNOSIS
Hospital: ……………………………………………
Date of registration .....................................................................................................................................
Patient study number: |___|___|___|___|
[dd/mm/yyyy]
|___||___||______|
[dd/mm/yyyy]
|___||___||______|
PATIENT CHARACTERISTICS AT DIAGNOSIS
Date of birth .............................................................................................................................................................
Sex ..........................................................................................................................................................................................
|__|
Postal code...............................................................................................................................................................
|______|
Hospital of diagnosis ...............................................................................................................................
Date: |___||___||______|
code on hospital list
Name: ……………………………………
1=male 2=female
|__|__|__|
Signature: ………………………………………
Version: 27 March 2013
page 2 of 4
PART I CML
REGISTRATION AND DIAGNOSIS
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
CLINICAL DATA BEFORE ANY TREATMENT
Date of diagnosis CML ...................................................................................
[dd/mm/yyyy]
|___||___||______|
|__|
Phase of disease at diagnosis
0= chronic phase
1= accelerated phase
2= blastic phase
9= unknown
Weight at diagnosis ..............................................................................................
[kg]
|__|__|__|
999= unknown
Height at diagnosis ................................................................................................
[cm]
|__|__|__|
999= unknown
ECOG/WHO score.................................................................................................
|__|
0= asymptomatic
1= symptomatic, but completely ambulatory
2= symptomatic, <50% in bed during day
3= symptomatic, >50% in bed, not bedbound
4= bedbound
5= dead
9= unknown
CML related symptoms present at diagnosis:
Weight loss in 6 months prior to diagnosis .................
|__| 0=no
Fever (>38 C) ..................................................................................................................
|__|
0=no
1=yes
9=unknown
Abdominal pain.............................................................................................................
|__|
0=no 1=yes
9=unknown
Bone pain ...............................................................................................................................
|__|
0=no 1=yes
9=unknown
fatigue ...........................................................................................................................................
|__|
0=no 1=yes
9=unknown
infection......................................................................................................................................
|__|
0=no 1=yes
9=unknown
Hemorrhagic syndrome .................................................................................
|__|
0=no 1=yes
9=unknown
Other ...............................................................................................................................................
|__|
9=unknown 0=no
Spleen size ..........................................................................................................................
|__|
Spleen size .......................................................................................................................... [cm below costal margin]
|__|__|.|__|
comorbidities ....................................................................................................................
|__|
Date: |___||___||______|
Name: ……………………………………
1=>5≤10% 2= >10≤20% 3 = >20% 4 = yes 9=unknown
0= normal
1=yes, specify……………………….
1= enlarged
9=unknown
99.9= unknown
0=no 1=yes, fill out comorbidity form
9= unknown
Signature: ………………………………………
Version: 27 March 2013
page 3 of 4
PART I CML
REGISTRATION AND DIAGNOSIS
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
PERIPHERAL BLOOD DATA
|__|
Date lab before treatment ........................................................................
0=before treatment
1=any date, if data before
treatment are not available
|___||___||______|
Blood sampling date ..........................................................................................
[dd/mm/yyyy]
Hemoglobine ...................................................................................................................
[mmol/l]
|__|__|.|__|
[g/dl]
|__|__|.|__|
|__|. |__|__|
Ht ..........................................................................................................................................................
9
|__|__|__|__|
9
|__|__|__|.|__|
Platelets....................................................................................................................................
[x10 /l]
WBC................................................................................................................................................
[x10 /l]
Blasts.......................................................................................................................
[%]
|__|__|__|
Eosinophils....................................................................................................
[%]
|__|__|__|
Basophils..........................................................................................................
[%]
|__|__|__|
BONE MARROW
|__|
cytology .....................................................................................................................................
cytology .....................................................................................................................................
[%]
histology ...................................................................................................................................
|__|__|__|
|__|
histology ...................................................................................................................................
[%]
0= not done
1= done
999= unknown
0= not done
1= done
|__|__|__|
999= unknown
|__|
1=yes
CYTOGENETICS
Cytogenetic study ...................................................................................................
Date of first cytogenetic test.................................................................
[dd/mm/yyyy]
0=no
|___||___||______|
Chromosome banding ....................................................................................
|__|
Number of evaluated metaphases ...........................................
|__|__| 99=unknown
Ph+ t(9;22)(q34;q11) .........................................................................................
|__|
Number of Ph+ metaphases ...............................................................
|__|__|
% of Ph+ metaphases ....................................................................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
Abnormalities present in phi + or phi - cells .............
Date: |___||___||______|
0=no
1=yes
0=no
1=yes
9=unknown
9=unknown
|__|__|__|
|__|__|
88= other, specify………………………………
|__|__|__|
|__|
Name: ……………………………………
999=unknown/not aplicable
1= phi +
2= phi -
3= both 9= unknown/ not appl.
Signature: ………………………………………
Version: 27 March 2013
page 4 of 4
PART I CML
REGISTRATION AND DIAGNOSIS
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
FISH
|__|
FISH analysis .................................................................................................................
Date of FISH analysis.............................................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
Material assessable ............................................................................................
|__|
Number of scored nuclei (total) ......................................................
|__|__|__|
999=unknown
Number of t(9;22) positive nuclei ................................................
|__|__|__|
999=unknown
|__|__|__|
999=unknown
percentage of t(9;22) positive nuclei .....................................
%
|__|
Other abnormalities .............................................................................................
0=no
1=yes
9=unknown 0=no 1=yes, specify:…………………
……………………………………………………………………..
MOLECULAR BIOLOGY
|__|
Molecular test done .............................................................................................
Date of molecular test ............................................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB 2= BM + PB 9=unknown
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL transcript type ............................................................................
|__|
1=b2a2 (=e13a2) 3= both, predominantly b2a2 5= both, equally present
2= b3a2 (=e14a2) 4= both, predominantly b3a2
8= other (i.e. e1a2), specify……………………………………
9= unknown
|__|
Control gene ............................................................................................................................
0=ABL
3=BCR
4= PBGD
1=β2M
8=other, specify…………………………….
2=GUS
9=unknown
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__|
International scale for BCR-ABL used? ..........................
|__|
0=no
1=yes
|__|
0=no
1=yes
0= negative 1= positive
11x9=unknown
9=unknown
MUTATIONAL ANALYSIS
Mutational analysis done ...........................................................................
Date of mutational analysis
........................................................................
[dd/mm/yyyy]
|__|
Mutation present
Type of mutation .......................................................................................................
Date: |___||___||______|
|___||___||______|
See list
0=no
|__|__|
Name: ……………………………………
1=yes
9=unknown
88= other, specify……………………………………………..
Signature: ………………………………………
Version: 27 March 2013
PART II CML
TREATMENT
Instructions: Please complete forms each year after registration
Patient study number: |___|___|___|___|
Hospital: ……………………………………………
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
TRIAL PARTICIPATION
|__|
Enrollment in a clinical study not previously
0=no
1=yes
9=unknown
reported.........................................................................................................................
|__|
If yes, please specify: ..........................................................................
st
9= unknown 1= H78 2= ENEST2nd 3=ENEST 1 , 4= PACE
5= SKI 6=other specified……………………………………….
Investigator sponsored trial .......................................................
|__|
0=no
1=yes
9=unknown
Company sponsored trial ..............................................................
|__|
0=no
1=yes
9=unknown
MEDICATION
medication Date start continuing Date end lijn Daily dose Reason change treatment Medication:
Continuing:
Reason dose change:
1= hydroxyurea
0= no
1= side effects, specify
2= interferon (IFN- α)
1= yes
2= treatment failure, specify
3= imatinib (glivec)
3= both 1+2, specify
4= nilotinib (tasigna)
4= start TKI
5= dasatinib (sprycel)
5= stopped per protocol
6= bosutinib (SKI 606)
6= stopped per protocol because of 1 year CMR
7= ponatinib
7= stopped per protocol because of 2 years CMR
8= ara-c
8= not applicable
88= other, specify
88= other, specify
99= unknown
Date: |___||___||______|
Name: ……………………………………
Signature: ………………………………………
Version: 27 March 2013
PART II CML
TREATMENT
Instructions: Please complete forms each year after registration
Patient study number: |___|___|___|___|
Hospital: ……………………………………………
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
TRANSPLANTATION
|__|
Allogeneic SCT................................................................................................
Date of transplantation...................................................
[dd/mm/yyyy]
1=yes
|___||___||______|
|__|
Reason for transplantation......................................
0=no
0= AP
1= BC
2= TK failure
3= TK intolerance
4= other, specify…………………………………………….
lijn ......................................................................................................................
|__|
1-9
Type of transplantation ..................................................
|__|
0= HLA identical sibling
1= haploidentical parent
2= syngene donor
4= matched unrelated donor
5= unrelated donor with mismatch
6= autoSCT
7= cordblood
9= unknown
|__|
|__|
Gender of donor ...........................................................................
Source of stem cells ..............................................................
0=male
1=female
9=unknown
0= peripheral blood 1= bonemarrow 2= cordblood 9= unknown
Conditioning
.
MEDICATION
CUM. DOSIS
Total Body Irradiation (TBI)
MEDICATION
Busulfan
[mg/kg]
Fludarabine
2
[mg/m ]
ATG horse
[mg/kg]
Cyclofosfamide
[mg/kg]
ATG rabbit
[mg/kg]
Alemtuzumab
Melfalan
[Gy]
CUM. DOSIS
[mg]
2
[mg/m ]
Other, specify:__________________________________
Date: |___||___||______|
BEAM
BBEAM
Unknown
Name: ……………………………………
Signature: ………………………………………
Version: 27 March 2013
page 1 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
HEMATOLOGIC DATA (PB) at dates of changes in response since last follow up
|__|
Hematologic response changed ...................................................
Date of hematologic evaluation......................................................
[dd/mm/yyyy]
Hemoglobine ...................................................................................................................
1= yes
|___||___||______|
|__|
Response status changed to ..............................................................
0=no
0=no response
[mmol/l]
|__|__|.|__|
[g/dl]
|__|__|.|__|
1= CHR
2= AP 3= BC 4= CP
|__|. |__|__|
Ht ..........................................................................................................................................................
9
|__|__|__|__|
9
|__|__|__|.|__|
Platelets....................................................................................................................................
[x10 /l]
WBC................................................................................................................................................
[x10 /l]
Blasts.......................................................................................................................
[%]
|__|__|__|
Eosinophils....................................................................................................
[%]
|__|__|__|
Basophils..........................................................................................................
[%]
|__|__|__|
HEMATOLOGIC DATA (PB) at dates of changes in response since last follow up
|__|
Hematologic response changed ...................................................
Date of hematologic evaluation......................................................
[dd/mm/yyyy]
Hemoglobine ...................................................................................................................
0=no response
[mmol/l]
|__|__|.|__|
[g/dl]
|__|__|.|__|
1= CHR
2= AP 3= BC 4= CP
|__|. |__|__|
Ht ..........................................................................................................................................................
9
|__|__|__|__|
9
|__|__|__|.|__|
Platelets....................................................................................................................................
[x10 /l]
WBC................................................................................................................................................
[x10 /l]
Blasts.......................................................................................................................
[%]
|__|__|__|
Eosinophils....................................................................................................
[%]
|__|__|__|
Basophils..........................................................................................................
[%]
|__|__|__|
Date: |___||___||______|
1= yes
|___||___||______|
|__|
Response status changed to ..............................................................
0=no
Name: ……………………………………
Signature: ………………………………………
Version: 27 March 2013
page 2 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
HEMATOLOGIC DATA (PB) at dates of changes in response since last follow up
|__|
Hematologic response changed ...................................................
Date of hematologic evaluation......................................................
[dd/mm/yyyy]
Hemoglobine ...................................................................................................................
1= yes
|___||___||______|
|__|
Response status changed to ..............................................................
0=no
0=no response
[mmol/l]
|__|__|.|__|
[g/dl]
|__|__|.|__|
1= CHR
2= AP 3= BC 4= CP
|__|. |__|__|
Ht ..........................................................................................................................................................
9
|__|__|__|__|
9
|__|__|__|.|__|
Platelets....................................................................................................................................
[x10 /l]
WBC................................................................................................................................................
[x10 /l]
Blasts.......................................................................................................................
[%]
|__|__|__|
Eosinophils....................................................................................................
[%]
|__|__|__|
Basophils..........................................................................................................
[%]
|__|__|__|
HEMATOLOGIC DATA (PB) at dates of changes in response since last follow up
|__|
Hematologic response changed ...................................................
Date of hematologic evaluation......................................................
[dd/mm/yyyy]
Hemoglobine ...................................................................................................................
0=no response
[mmol/l]
|__|__|.|__|
[g/dl]
|__|__|.|__|
1= CHR
2= AP 3= BC 4= CP
|__|. |__|__|
Ht ..........................................................................................................................................................
9
|__|__|__|__|
9
|__|__|__|.|__|
Platelets....................................................................................................................................
[x10 /l]
WBC................................................................................................................................................
[x10 /l]
Blasts.......................................................................................................................
[%]
|__|__|__|
Eosinophils....................................................................................................
[%]
|__|__|__|
Basophils..........................................................................................................
[%]
|__|__|__|
Date: |___||___||______|
1= yes
|___||___||______|
|__|
Response status changed to ..............................................................
0=no
Name: ……………………………………
Signature: ………………………………………
Version: 27 March 2013
page 3 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
HEMATOLOGIC DATA (PB) at date one year since last follow up
Date of hematologic evaluation......................................................
[dd/mm/yyyy]
|__|
Response status .......................................................................................................
Hemoglobine ...................................................................................................................
|___||___||______|
0=no response
[mmol/l]
|__|__|.|__|
[g/dl]
|__|__|.|__|
1= CHR
2= AP 3= BC 4= CP
|__|. |__|__|
Ht ..........................................................................................................................................................
9
|__|__|__|__|
9
|__|__|__|.|__|
Platelets....................................................................................................................................
[x10 /l]
WBC................................................................................................................................................
[x10 /l]
Blasts.......................................................................................................................
[%]
|__|__|__|
Eosinophils....................................................................................................
[%]
|__|__|__|
Basophils..........................................................................................................
[%]
|__|__|__|
BONE MARROW
|__|
cytology .....................................................................................................................................
Date of cytology .........................................................................................................
[dd/mm/yyyy]
blasts .............................................................................................................................................
[%]
Date of histology .......................................................................................................
[dd/mm/yyyy]
histology ...................................................................................................................................
[%]
1= done
|___||___||______|
|__|__|__|
|__|
histology ...................................................................................................................................
0= not done
999= unknown
0= not done
1= done
|___||___||______|
|__|__|__|
999= unknown
BONE MARROW
|__|
cytology............................................................
Date of cytology ...............................................
[dd/mm/yyyy]
blasts................................................................
[%]
Date of histology ..............................................
[dd/mm/yyyy]
histology...........................................................
[%]
Date: |___||___||______|
1= done
|___||___||______|
|__|__|__|
|__|
histology...........................................................
0= not done
999= unknown
0= not done
1= done
|___||___||______|
|__|__|__|
Name: ……………………………………
999= unknown
Signature: ………………………………………
Version: 27 March 2013
page 4 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
BONE MARROW
|__|
cytology............................................................
Date of cytology ...............................................
[dd/mm/yyyy]
blasts................................................................
[%]
Date of histology ..............................................
[dd/mm/yyyy]
histology...........................................................
[%]
1= done
|___||___||______|
|__|__|__|
|__|
histology...........................................................
0= not done
999= unknown
0= not done
1= done
|___||___||______|
|__|__|__|
999= unknown
BONE MARROW
|__|
cytology............................................................
Date of cytology ...............................................
[dd/mm/yyyy]
blasts................................................................
[%]
Date of histology ..............................................
[dd/mm/yyyy]
histology...........................................................
[%]
1= done
|___||___||______|
|__|__|__|
|__|
histology...........................................................
0= not done
999= unknown
0= not done
1= done
|___||___||______|
|__|__|__|
999= unknown
|__|
1=yes
CYTOGENETICS
Cytogenetic study ............................................
Date of cytogenetic test....................................
[dd/mm/yyyy]
0=no
|___||___||______|
Material assessable ............................................................................................
|__|
Number of evaluated metaphases ...................
|__|__| 99=unknown
Ph+ t(9;22)(q34;q11)........................................
|__|
Number of Ph+ metaphases ............................
|__|__|
% of Ph+ metaphases......................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
Abnormalities present in phi + or phi - cells .............
Current response .........................................................................................................
Date: |___||___||______|
0=no
1=yes
0=no
1=yes
9=unknown
|__|__|__|
|__|
88= other, specify………………………………………
|__|__|__|
|__|
|__|
999=unknown/not aplicable
1= phi +
2= phi -
1= CCgR 2= PCgR
Name: ……………………………………
3= both 9= unknown/ not appl.
3= minor CgR 4= no CgR
Signature: ………………………………………
Version: 27 March 2013
page 5 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
CYTOGENETICS
|__|
Cytogenetic study ............................................
Date of cytogenetic test....................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
Material assessable ............................................................................................
|__|
Number of evaluated metaphases ...................
|__|__| 99=unknown
Ph+ t(9;22)(q34;q11)........................................
|__|
Number of Ph+ metaphases ............................
|__|__|
% of Ph+ metaphases......................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
|__|
0=no
1=yes
9=unknown
88= other, specify………………………………………
|__|__|__|
|__|
Current response .........................................................................................................
1=yes
|__|__|__|
|__|
Abnormalities present in phi + or phi - cells .............
0=no
999=unknown/not aplicable
1= phi +
2= phi -
1= CCgR 2= PCgR
3= both 9= unknown/ not appl.
3= minor CgR 4= no CgR
CYTOGENETICS
|__|
Cytogenetic study ............................................
Date of cytogenetic test....................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
Material assessable ............................................................................................
|__|
Number of evaluated metaphases ...................
|__|__| 99=unknown
Ph+ t(9;22)(q34;q11)........................................
|__|
Number of Ph+ metaphases ............................
|__|__|
% of Ph+ metaphases......................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
Abnormalities present in phi + or phi - cells .............
Current response .........................................................................................................
Date: |___||___||______|
0=no
1=yes
0=no
1=yes
9=unknown
|__|__|__|
|__|
88= other, specify………………………………………
|__|__|__|
|__|
|__|
999=unknown/not aplicable
1= phi +
2= phi -
1= CCgR 2= PCgR
Name: ……………………………………
3= both 9= unknown/ not appl.
3= minor CgR 4= no CgR
Signature: ………………………………………
Version: 27 March 2013
page 6 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
CYTOGENETICS
|__|
Cytogenetic study ............................................
Date of cytogenetic test....................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
Material assessable ............................................................................................
|__|
Number of evaluated metaphases ...................
|__|__| 99=unknown
Ph+ t(9;22)(q34;q11)........................................
|__|
Number of Ph+ metaphases ............................
|__|__|
% of Ph+ metaphases......................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
|__|
0=no
1=yes
9=unknown
88= other, specify………………………………………
|__|__|__|
|__|
Current response .........................................................................................................
1=yes
|__|__|__|
|__|
Abnormalities present in phi + or phi - cells .............
0=no
999=unknown/not aplicable
1= phi +
2= phi -
1= CCgR 2= PCgR
3= both 9= unknown/ not appl.
3= minor CgR 4= no CgR
FISH
|__|
FISH analysis .................................................................................................................
Date of FISH analysis...................................................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
Number of scored nuclei (total) ......................................................
|__|__|__|
999=unknown
Number of t(9;22) positive nuclei ................................................
|__|__|__|
999=unknown
|__|__|__|
999=unknown
percentage of t(9;22) positive nuclei .....................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
Abnormalities present in phi + or phi - cells .............
Current response .........................................................................................................
Date: |___||___||______|
2= BM + PB
9=unknown
|__|__| 88= other, specify………………………………………
|__|__|__|
|__|
|__|
999=unknown/not aplicable
1= phi +
2= phi -
1= CCgR 2= PCgR
Name: ……………………………………
3= both 9= unknown/ not appl.
3= minor CgR 4= no CgR
Signature: ………………………………………
Version: 27 March 2013
page 7 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
[dd/mm/yyyy]
FISH
|__|
FISH analysis .................................................................................................................
Date of FISH analysis...................................................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
Number of scored nuclei (total) ......................................................
|__|__|__|
999=unknown
Number of t(9;22) positive nuclei ................................................
|__|__|__|
999=unknown
|__|__|__|
999=unknown
percentage of t(9;22) positive nuclei .....................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
|__|__|
|__|
Current response .........................................................................................................
9=unknown
88= other, specify………………………………………
|__|__|__|
|__|
Abnormalities present in phi + or phi - cells .............
2= BM + PB
999=unknown/not aplicable
1= phi +
2= phi -
1= CCgR 2= PCgR
3= both 9= unknown/ not appl.
3= minor CgR 4= no CgR
FISH
|__|
FISH analysis .................................................................................................................
Date of FISH analysis...................................................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
Number of scored nuclei (total) ......................................................
|__|__|__|
999=unknown
Number of t(9;22) positive nuclei ................................................
|__|__|__|
999=unknown
|__|__|__|
999=unknown
percentage of t(9;22) positive nuclei .....................................
%
Other chromosome abnormalities .............................................
See list
% of other chromosome abnormalities .............................
%
Abnormalities present in phi + or phi - cells .............
Current response .........................................................................................................
Date: |___||___||______|
|__|__|
|__|
999=unknown/not aplicable
1= phi +
2= phi -
1= CCgR 2= PCgR
Name: ……………………………………
9=unknown
88= other, specify………………………………………
|__|__|__|
|__|
2= BM + PB
3= both 9= unknown/ not appl.
3= minor CgR 4= no CgR
Signature: ………………………………………
Version: 27 March 2013
page 8 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
0=no
1=yes
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
Date of molecular test
................................................................................................
[dd/mm/yyyy]
9=unknown
2= BM + PB
9=unknown
|___||___||______|
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MOLECULAR BIOLOGY
molecular test done
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
material ......................................................................................................................................
Material assessable ............................................................................................
|__| 0=no 1=yes 9=unknown
|___||___||______|
|__| 0=BM 1=PB 2= BM + PB
|__| 0=no 1=yes
9=unknown
|__| 0= negative 1= positive 2= positive, not quantifiable
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
|__| 0=no 1=yes 9=unknown
|__| 1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
BCR-ABL / control .................................................................................................
BCR-ABL / control ratio ................................................................................
International scale used............................................................................................
Current response .........................................................................................................
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
2= BM + PB
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
Date: |___||___||______|
9=unknown
Name: ……………………………………
6= ≥ 2 < 3 reduction
Signature: ………………………………………
Version: 27 March 2013
page 9 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
2= BM + PB
9=unknown
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MOLECULAR BIOLOGY
molecular test done
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
material ......................................................................................................................................
Material assessable ............................................................................................
BCR-ABL / control .................................................................................................
BCR-ABL / control ratio ................................................................................
International scale used............................................................................................
Current response .........................................................................................................
|__| 0=no 1=yes 9=unknown
|___||___||______|
|__| 0=BM 1=PB 2= BM + PB 9=unknown
|__| 0=no 1=yes
|__| 0= negative 1= positive 2= positive, not quantifiable
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
|__| 0=no 1=yes 9=unknown
|__| 1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
2= BM + PB
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
Date: |___||___||______|
9=unknown
Name: ……………………………………
6= ≥ 2 < 3 reduction
Signature: ………………………………………
Version: 27 March 2013
page 10 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
2= BM + PB
9=unknown
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MOLECULAR BIOLOGY
molecular test done
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
material ......................................................................................................................................
Material assessable ............................................................................................
BCR-ABL / control .................................................................................................
BCR-ABL / control ratio ................................................................................
International scale used............................................................................................
Current response .........................................................................................................
|__| 0=no 1=yes 9=unknown
|___||___||______|
|__| 0=BM 1=PB 2= BM + PB 9=unknown
|__| 0=no 1=yes
|__| 0= negative 1= positive 2= positive, not quantifiable
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
|__| 0=no 1=yes 9=unknown
|__| 1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
2= BM + PB
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
Date: |___||___||______|
9=unknown
Name: ……………………………………
6= ≥ 2 < 3 reduction
Signature: ………………………………………
Version: 27 March 2013
page 11 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
2= BM + PB
9=unknown
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MOLECULAR BIOLOGY
molecular test done
|__|
........................................................................................................
Date of molecular test
................................................................................................
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|___||___||______|
material ......................................................................................................................................
|__|
0=BM
1=PB
Material assessable ............................................................................................
|__|
0=no
1=yes
BCR-ABL / control .................................................................................................
|__|
BCR-ABL / control ratio ................................................................................
|__|__|__|.|__|__|__|__|__|__|__|__| 11x9=unknown
International scale used............................................................................................
|__|
Current response .........................................................................................................
|__|
2= BM + PB
9=unknown
0= negative 1= positive 2= positive, not quantifiable
0=no
1=yes
9=unknown
1= CMR 2= MMR 3= no reduction 4= < 1 log reduction
5= ≥1 < 2 log reduction
6= ≥ 2 < 3 reduction
MUTATIONAL ANALYSIS
mutational analysis done
|__|
......................................................................................
Date of mutational analysis
..............................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
Material assessable ............................................................................................
|__|
0=no
1=yes
Mutation present
|__|
0=no
1=yes
Type of mutation .......................................................................................................
Date: |___||___||______|
See list
9=unknown
|__|__|
Name: ……………………………………
9=unknown
88= other, specify………………………….
Signature: ………………………………………
Version: 27 March 2013
page 12 of 12
PART II CML
RESPONSE EVALUATION
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
MUTATIONAL ANALYSIS
mutational analysis done
|__|
......................................................................................
Date of mutational analysis
..............................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
Material assessable ............................................................................................
|__|
0=no
1=yes
Mutation present
|__|
0=no
1=yes
Type of mutation .......................................................................................................
See list
9=unknown
|__|__|
9=unknown
88= other, specify………………………….
MUTATIONAL ANALYSIS
mutational analysis done
|__|
......................................................................................
Date of mutational analysis
..............................................................................
[dd/mm/yyyy]
0=no
1=yes
|___||___||______|
Material assessable ............................................................................................
|__|
0=no
1=yes
Mutation present
|__|
0=no
1=yes
Type of mutation .......................................................................................................
Date: |___||___||______|
See list
9=unknown
|__|__|
Name: ……………………………………
9=unknown
88= other, specify………………………….
Signature: ………………………………………
Version: 27 March 2013
page 1 of 1
PART II CML
PATIENT CONDITION
Patient study number: |___|___|___|___|
Hospital: ……………………………………………
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
SURVIVAL STATUS
Date of last contact ................................................
[dd/mm/yyyy]
|___||___||______|
|__|
ECOG/WHO score .................................................
0= asymptomatic
1= symptomatic, but completely ambulatory
2= symptomatic, <50% in bed during day
3= symptomatic, >50% in bed, not bedbound
4= bedbound
5= dead
9= unknown
|__|
Death .....................................................................
If yes, date of death..........................................
[dd/mm/yyyy]
1=yes,
9=unknown
|___||___||______|
|__|
Cause of death.................................................
0=no
0=CML
1= comorbidity/AE after treatment
2= pre-existent comorbidity
3= infection
4= other
9= unknown
Specify……………………………………………………………
………………………………………………………………………
………………………………………………………………………
………………………………………………………………………
|__|
Patient referred to another hospital during this year
If yes, hospital patient is referred to ..........................
If yes, date of referral .......................................
See list
[dd/mm/yyyy]
0=no
1=yes
9=unknown
|__|__|__|
|___||___||______|
01 01 9999= unknown
SERIOUS ADVERSE EVENTS (SAES) AND GRADE 3 / 4 ADVERSE EVENTS (AES)
SAE ...............................................................................................................................................................
|__|
0=no
1=yes, please fill out (S)AE form
AE grade 3 / 4 ...............................................................................................................
|__|
0=no
1=yes, please fill out (S)AE form
COMMENTS
....................................................................................................................................................................................................…………
....................................................................................................................................................................................................…………
....................................................................................................................................................................................................…………
Date: |___||___||______|
Name: ……………………………………
Signature: ………………………………………
Version: 27 March 2013
page 1 of 1
PART II CML
PREGNANCY FORM
Patient study number: |___|___|___|___|
Hospital: ……………………………………………
|__| 1=1
Year after diagnosis ...............................................................................
Date ..........................................................................................................................
[dd/mm/yyyy]
2=2 3=3 4=4 5=5 6=6 7=7 8=8 9=9
|___||___||______|
SUBJECT INFORMATION
Pregnancy since registration / last follow up .......................
|__|
0=no
Who has become pregnant ................................................................................
|__|
1= female patient
1=yes
Start date of last menses........................................................................................
[dd/mm/yyyy]
|___||___||______|
Date pregnancy confirmed ..................................................................................
[dd/mm/yyyy]
|___||___||______|
Anticipated date of childbirth ............................................................................
[dd/mm/yyyy]
|___||___||______|
Date of childbirth....................................................................................................................
[dd/mm/yyyy]
|___||___||______|
2= partner of male patient
MEDICATION AND OUTCOME
|__|
Last given treatment at time of conception ............................
*specify
1= hydroxyurea
2= IFN-α
3= imatinib
4= dasatinib
5= nilotinib
6= bosutinib
7= ponatinib
8=*combination
9= *other
____________________________________
|__|
Action taken regarding treatment ............................................................
0= no treatment yet
0= no change
1= discontinued temporarily
2= discontinued permanently
3= dose reduced: to___________________
4= medication change to plasmaferese
5= medication change to hydrea
6= medication change to IFN-a
7= medication change to imatinib
8= medication change to dasatinib
9= medication change to nilotinib
10= medication change to bosutinib
11= medication change to ponatinib
88= medication change to:
______________
|__|
Pregnancy outcome .........................................................................................................
1= not known at this date
2= uneventful (normal/healthy baby)
*specify
Date: |___||___||______|
3= induced abortion
4= spontaneaous abortion
5= still birth
6= neonatal death
7= *birth defects
8= *other
____________________________________
Name: ……………………………………
Signature: ………………………………………
Version: 27 March 2013
page 1 of 1
PART II CML
GENERAL COMMENTS
Hospital: ……………………………………………
Patient study number: |___|___|___|___|
....................................................................................................................................................................................................…………
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....................................................................................................................................................................................................…………
....................................................................................................................................................................................................…………
Date: |___||___||______|
Name: ……………………………………
Signature: ………………………………………
Version: 27 March 2013
COMORBIDITY / ADVERSE EVENT / SERIOUS ADVERSE EVENT FORM CML
Please use CTCAE version 3.0. Please report AE’s grade 3 / 4 / 5 only
Hospital: ……………………………………………
Category Comorbidity / Adverse Event term
please use comorbidity / AE list
Patient study number: |___|___|___|
Related to CML
Date start
Date end
0= no
treatment according
01-01-9999 = unknown
01-01-9999= unknown
1= yes
to physician
SAE
CTCAE grade
|__|__|
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Version: 27 March 2013
COMORBIDITY / ADVERSE EVENTS CODES
CATEGORY according to CTCAE v3.0
1
ALLERGY/IMMUNOLOGY
15
INFECTION
2
AUDITORY/EAR
16
LYMPHATICS
3
BLOOD/BONE MARROW
17
METABOLIC/LABORATORY
4
CARDIAC ARRHYTHMIA
18
MUSCULOSKELETAL/SOFT TISSUE
5
CARDIAC GENERAL
19
NEUROLOGY
6
COAGULATION
20
OCULAR/VISUAL
7
CONSTITUTIONAL SYMPTOMS
21
PAIN
8
DEATH
22
PULMONARY/UPPER RESPIRATORY
9
DERMATOLOGY/SKIN
23
RENAL/GENITOURINARY
10 ENDOCRINE
24
SECONDARY MALIGNANCY
11 GASTROINTESTINAL
25
SEXUAL/REPRODUCTIVE FUNCTION
12 GROWTH AND DEVELOPMENT
26
SURGERY/INTRA-OPERATIVE INJURY
13 HEMORRHAGE/BLEEDING
27
SYNDROMES
14 HEPATOBILIARY/PANCREAS
28
VASCULAR
29 OTHER
An increase in the severity of a concomitant disease that was present at baseline is to be considered an Adverse Event. Any ongoing Adverse Event that increases in severity is
to be treated as a new Adverse Event. A decrease in the severity of an Adverse Event that continues to be ‘ongoing’ should not be reported on the Adverse Event Form.
The form allows for 15 Adverse Events per page. To report more, make as many copies as you need.
AE nr: assign a number to each reported AE; start with AE nr ‘001’ and continue numbering upwards for each following AE that is reported.
Category: mark the appropriate Category for the AE according to the CTCAE list (version 3.0)
Adverse Event term: use the Short Name from the CTCAE list. If no appropriate Short Name is available, use the term ‘other’ followed by a specification. This specification
should be a short diagnostic term and not an elaborate description. Include the specification from the Select list if this is applicable to the AE term. For example: describe the AE
as ‘Ulcer, GI – Duodenum’; where ‘Ulcer, GI’ is the Short Name and ‘Duodenum’ is added as the Select specification (page 28 of the CTCAE list), to distinguish it from ulcers
located elsewhere in the GI tract. Please continue to use the same AE term as before when reporting a new AE that is the result of an increase in severity of an ongoing AE or
concomitant disease.
CTCAE grade: note the highest CTCAE grade that was observed during the associated treatment period.
Related to CML treatment: 0= unsuspected 1= suspected 9= no comment in source about this issue