Version: Nov. 2002 Therapy Study EURO-LB 02 Space for the address of the responsible data centre Registration All patients who fulfil the registration criteria are registered in the study, regardless whether they are eligible for treatment response or randomisation. The registration fax must be sent to the responsible data centre within 7 days after the beginning of the prephase. Surname (or initial): _____________________________ First name (or initial): ______________________________ Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) (age at diagnosis < 22 years) sex: male female Lymphoblastic lymphoma diagnosed by histomorphological and/or cytomorphological characterisation? no yes Signed informed consent for participation in the study EURO-LB 02? no yes For female patients: Pregnancy or lactation period? no yes Simultaneous participation in another clinical study? no yes If "yes": which clinical study? _________________________________________________________ HIV infection or AIDS? no yes Severe immunodeficiency? no yes If "yes": specify: ______________________________________________________________________ Previous organ transplantation? no yes If "yes": specify: ______________________________________________________________________ Previous malignancy? no yes If "yes": specify: ______________________________________________________________________ Other pre-existing disease prohibiting chemotherapy as per instruction of the Protocol? no yes If "yes": specify: ______________________________________________________________________ Previous chemotherapy? no yes If "yes": specify: ______________________________________________________________________ Previous radiotherapy? no yes If "yes": specify: ______________________________________________________________________ Previous systemic corticosteroid treatment for more than 8 days within two months before the beginning of therapy according to the Protocol EURO-LB 02? no yes If "yes": specify: ______________________________________________________________________ For T-cell lymphoblastic lymphoma: Please send the fax for the 1 st randomisation (Prednisone vs Dexamethasone) to the responsible data centre! If no randomisation should be performed, please give the reason: due to patients/guardians refusal due to physician's refusal other reason: ______________________________________________________________________________ Please indicate, which therapy was selected: ________________________________ PRED DEXA Study Group: ___________________________________ Treating centre: ___________________________________ Responsible physician: _________________________________________________________________________________ Phone:_______________________________________________ Fax: _________________________________________ _______________________________ _______________ _______________________________ ___________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature responsible physician
Transcript
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
RegistrationAll patients who fulfil the registration criteria are registered in the study, regardless whether they are eligible for treatment
response or randomisation. The registration fax must be sent to the responsible data centre within 7 days after the beginning ofthe prephase.
Surname (or initial):_____________________________ First name (or initial): ______________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) (age at diagnosis < 22 years)
sex: male female
Lymphoblastic lymphoma diagnosed by histomorphological and/or cytomorphological characterisation? no yes
Signed informed consent for participation in the study EURO-LB 02? no yes
For female patients: Pregnancy or lactation period? no yes
Simultaneous participation in another clinical study? no yes If "yes": which clinical study? _________________________________________________________
HIV infection or AIDS? no yes
Severe immunodeficiency? no yesIf "yes": specify: ______________________________________________________________________
Previous organ transplantation? no yesIf "yes": specify: ______________________________________________________________________
Previous malignancy? no yesIf "yes": specify: ______________________________________________________________________
Other pre-existing disease prohibiting chemotherapy as per instruction of the Protocol? no yes If "yes": specify: ______________________________________________________________________
Previous chemotherapy? no yes If "yes": specify: ______________________________________________________________________
Previous radiotherapy? no yes If "yes": specify: ______________________________________________________________________
Previous systemic corticosteroid treatment for more than 8 days within two months before the beginning of therapy according to the Protocol EURO-LB 02? no yes
If "yes": specify: ______________________________________________________________________
For T-cell lymphoblastic lymphoma: Please send the fax for the 1st randomisation (Prednisone vs Dexamethasone) to the responsible data centre! If no randomisation should be performed, please give the reason:
due to patients/guardians refusaldue to physician's refusalother reason: ______________________________________________________________________________
Please indicate, which therapy was selected: ________________________________ PRED DEXA
Study Group: ___________________________________ Treating centre: ___________________________________
_______________________________ _______________ _______________________________ ___________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature
responsible physician
1/2Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Initial ObservationThe initial observation form should be sent within the first month after the beginning of therapy.
Surname (or initial): ___________________________________ First name (or initial): __________________________________Date of birth: |__|__|.|__|__|.|__|__|
(dd mm yy)Sex: male female Registration number: |__|__|__|__|__|
(if known)
Please note: before sending this form to the responsible data centre, the informed consent for data exchange, digital data storage and data processing must be signed by patient / guardian(s)
General condition at diagnosis (Karnofsky): normal activity, no impairment slight impairment of activity, requires no occasional assistance obvious normal activity, according to age bedridden, requires special care and assistance bedridden, very sick, in need of intensive care
General signs: no yes loss in weight (> 10% in last 6 months) fever (> 38°C for at least 7 days) night sweat
Diagnosis: by puncture: no no yes
yes: bone marrow before start of therapy ascites pleural effusion pericardial effusion
by surgery: no yes: fine-needle biopsy biopsy (partial-) resection
Date of diagnostic surgery / puncture: |__|__|.|__|__|.|__|__| (dd mm yy)
Blood: WBC (x 109/l): |__|__| . |__| platelets (x 109/l): |__|__|__| Hb (g/l): |__|__|__| before start of therapy
lymphoma-cells (%): |__|__|__| before start of therapy
Lymphoma-cells in bone marrow aspirates (%): |__|__|__| not done
CSF: nucleated cells /μl CSF: |__|__|__|__|__| before start of therapy erythrocytes /μl CSF: |__|__|__|__|__| before start of therapy lymphoma-cells /μl CSF: |__|__|__|__|__| before start of therapy
Biochemical parameters: Maximum increase of LDH before the start of therapy: |__|__|.|__| times upper normal limit according to age
Example: patient 8 years of age; maximum LDH before start of lymphoma treatment: 690 U/l local laboratory: upper normal limit according to age: 344 U/l 690 U/l : 344 U/l = 2 It should be filled in: Maximum increase of LDH before the start of therapy: |__|_2_|.|_0_| times upper normal limit according to age
Local diagnosis: Histology: diagnosis of lymphoblastic lymphoma: (Please send a copy of yes
the report to the no, responsible data centre!) diagnosis:_____________________
not done
Immunohistochemistry: (precursor-) T (Please send a copy of (precursor-) B the report to the bilineageresponsible data centre!) not definable
not done Cytomorphology/FAB: L1 (Please send a copy of L2
the report to the L1/L2 responsible data centre!) other:_________________________
not done
Immunology: (precursor-) T (Please send a copy of (precursor-) B the report to the bilineageresponsible data centre!) not definable
not done Reference diagnosis:
Reference histology initiated: no yes, at: __________________________ Please send a copy of the report to the responsible data centre!
Therapy: Stage I or II (Induction Phase I a/b Protocol M Maintenance) Stage III or IV (Induction Phase I a/b Protocol M Re-Induction II a/b Maintenance)
CNS treatment: CNS Type 1: negative CNS Type 2: positive CNS Type 3: blasts, but < 5 nucleated cells/μl CSF
Date of the beginning of the protocol therapy: |__|__|.|__|__|.|__|__| (dd mm yy)
Initial complications before start of therapy:
no yes Cell lysis syndrome Reduced renal function Reduced cardial function Paraplegia/paresis Life-threatening sepsis Life-threatening bleeding Complication(s) of primary surgery
no yesComplication(s) caused by a mediastinal tumour: Respiratory impairment Superior vena cava syndrome
Complication(s) caused by effusions: Respiratory impairment Superior vena cava syndrome
Folinic Acid Rescue 15 mg/m², i.v. at h 42, 48, 54 after the start of MTX infusion Please fill in the white fields in the table below!
42 48 54 42 48 54 42 48 54 42 48 54 �
Methotrexate i.th. age-adjusted dose
|__|__|mg � � � � �
1st HD-MTX 2nd HD-MTX 3rd HD-MTX 4th HD-MTX hour after start of MTX
infusionMTX level (μmol/l)
Creatinine times of upper normal limit
Folinic Acid Rescue (mg)
MTX level (μmol/l)
Creatinine times of upper normal limit
Folinic Acid Rescue (mg)
MTX level (μmol/l)
Creatinine times of upper normal limit
Folinic Acid Rescue (mg)
MTX level (μmol/l)
Creatinine times of upper normal limit
Folinic Acid Rescue (mg)
024
(36)4248 54
later Folinic Acid Rescue given after hour 54: � no � yes Folinic Acid Rescue given after hour 54: � no � yes Folinic Acid Rescue given after hour 54: � no � yes Folinic Acid Rescue given after hour 54: � no � yes
Remarks:
_____________________ __________________________________________________ ______________________________________ __________________________________Date Physician: Name Physician: Signature Hospital stamp
Version Nov. 2002
Re-Induction Protocol II
1 8 15 22 36 49Day 29
Dexamethasone
Vincristine
Cyclophosphamide
Methotrexate
Doxorubicin
E. coli Asparaginase
Cytarabine
6-Thioguanine
p.o.
i.v.
i.v. (1h)
i.v. (1h)
i.v.
p.o.
i.th.
11 18 38 45
10 mg/m2/d
1.5 mg/m2/d (max. 2 mg)
30 mg/m2 /d
10 000 U/m2 /d
1 000 mg/m2/d
75 mg/m2/d
60 mg/m2/d
EURO-LB 02 Version Nov. 2002
i.v. (1h)
Version Nov. 2002
Re - Inductions Phase II/a EURO-LB 02 Version Nov. 2002
Name :__________________________________________________________________________________ Date of birth: |__|__|.|__|__|.|__|__|
Number of tablets à 50 mg* |__|.|__| |__|.|__| |__|.|__| |__|.|__| |__|.|__| |__|.|__| |__|.|__| |__|.|__|
* information of number of tablets optional (if used as „handout“ for parents), not necessary for documentation Reasons for modification, if modification is necessary: - Haematological Toxicity no yes no yes no yes no yes no yes no yes no yes no yes
- Bilirubin > 3 x UNL (upper normal limit) no yes no yes no yes no yes no yes no yes no yes no yes
- Chronic diarrhoea no yes no yes no yes no yes no yes no yes no yes no yes
- MTX-pneumonitis no yes no yes no yes no yes no yes no yes no yes no yes
- Other reasons no yes no yes no yes no yes no yes no yes no yes no yes
- Infections no yes no yes no yes no yes no yes no yes no yes no yes
Please specify kind of infection in case of grade 3 or 4 infection (e.g. pneumonitis): __________________________________________
Osteonecrosis occurred? If "yes": please fill in the form "late effects"
no yes no yes no yes no yes no yes no yes no yes no yes
Remarks:
_____________________________ ________________ ________________________________ ________________________ Hospital Stamp Date (dd mm yy) Name (in block letters) Signature
responsib le phys ic ian
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
End of Treatment should be sent after end of maintenance therapy
Surname (or initial): _____________________________________ First name (or initial): ____________________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__|(if known)
End of maintenance therapy at |__|__|.|__|__|.|__|__| (dd mm yy)
Withdrawal of therapy? no yes, at |__|__|.|__|__|.|__|__| (dd mm yy)
Please give the reasons for the withdrawal:
CNS radiotherapy
CNS radiotherapy performed? no yes
Begin of CNS radiotherapy at |__|__|.|__|__|.|__|__| (dd mm yy)
End of CNS radiotherapy at |__|__|.|__|__|.|__|__| (dd mm yy)
Cumulative dose of CNS radiotherapy: |__|__|.|__| Gy
Number of single fractions of CNS radiotherapy: |__|__|__|
Remarks:
______________________ ___________________________ _______________ ______________________________ Signature Name (in block letters) Date (dd mm yy) Hospital Stamp
responsib le phys ic ian
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Acute toxicity during / after therapy elements of EURO-LB 02Surname (or initial): __________________________________ First name (or initial): _____________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Maximum toxicity during / after: Prephase I/a I/b M II/a II/b Begin of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy) End of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy)
Grade 0 1 2 3 4 not tested
Haematology Haemoglobin (g/l) normal for age 100 - < LLN 80 - < 100 65 - < 80 < 65
Thrombosis Thrombosis / embolism none - deep vein thrombosis,
not requiring anticoagulant
deep vein thrombosis, requiring anticoagulant
therapy
embolic event (including pulmonary embolism)
Neurological toxicityCentralneurotoxicity
none temporary lethargy somnolence < 50% of the time,
moderate disorientation
somnolence 50% of the time,
severe disorientation, hallucination
coma, seizures
Peripheralneurotoxicity
none paresthesia severe paresthesia and/or mild weakness
unbearable paresthesia, obvious deficits in motoric function
paralysis
Anaphylaxis Anaphylaxis none mild moderate severe life threatening
Osteonecrosis Osteonecrosis (avascular necrosis)
none asymptomatic and detected by imaging
only
symptomatic and interfering, but not
interfering with activities of daily living
symptomatic and interfering with activities
of daily living
symptomatic or disabling
Other toxicity: no yes (specify, and if possible, precise the NCI-grades: 0=normal; 1=mild; 2=moderate; 3=severe; 4=life-threatening)If case of SAE, please use the SAE-form
Abbreviations: EF = ejection fraction SF = shortening fraction LLN = lower normal limit UNL = upper normal limit TPN = total parenteral nutrition CHF = congestive hear failure
_____________________________ _______________ _______________________________ ____________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e p h y s i c i a n
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Acute toxicity during / after therapy elements of EURO-LB 02Surname (or initial): __________________________________ First name (or initial): _____________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Maximum toxicity during / after: Prephase I/a I/b M II/a II/b Begin of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy) End of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy)
Grade 0 1 2 3 4 not tested
Haematology Haemoglobin (g/l) normal for age 100 - < LLN 80 - < 100 65 - < 80 < 65
Thrombosis Thrombosis / embolism none - deep vein thrombosis,
not requiring anticoagulant
deep vein thrombosis, requiring anticoagulant
therapy
embolic event (including pulmonary embolism)
Neurological toxicityCentralneurotoxicity
none temporary lethargy somnolence < 50% of the time,
moderate disorientation
somnolence 50% of the time,
severe disorientation, hallucination
coma, seizures
Peripheralneurotoxicity
none paresthesia severe paresthesia and/or mild weakness
unbearable paresthesia, obvious deficits in motoric function
paralysis
Anaphylaxis Anaphylaxis none mild moderate severe life threatening
Osteonecrosis Osteonecrosis (avascular necrosis)
none asymptomatic and detected by imaging
only
symptomatic and interfering, but not
interfering with activities of daily living
symptomatic and interfering with activities
of daily living
symptomatic or disabling
Other toxicity: no yes (specify, and if possible, precise the NCI-grades: 0=normal; 1=mild; 2=moderate; 3=severe; 4=life-threatening)If case of SAE, please use the SAE-form
Abbreviations: EF = ejection fraction SF = shortening fraction LLN = lower normal limit UNL = upper normal limit TPN = total parenteral nutrition CHF = congestive hear failure
_____________________________ _______________ _______________________________ ____________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e p h y s i c i a n
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Acute toxicity during / after therapy elements of EURO-LB 02Surname (or initial): __________________________________ First name (or initial): _____________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Maximum toxicity during / after: Prephase I/a I/b M II/a II/b Begin of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy) End of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy)
Grade 0 1 2 3 4 not tested
Haematology Haemoglobin (g/l) normal for age 100 - < LLN 80 - < 100 65 - < 80 < 65
Thrombosis Thrombosis / embolism none - deep vein thrombosis,
not requiring anticoagulant
deep vein thrombosis, requiring anticoagulant
therapy
embolic event (including pulmonary embolism)
Neurological toxicityCentralneurotoxicity
none temporary lethargy somnolence < 50% of the time,
moderate disorientation
somnolence 50% of the time,
severe disorientation, hallucination
coma, seizures
Peripheralneurotoxicity
none paresthesia severe paresthesia and/or mild weakness
unbearable paresthesia, obvious deficits in motoric function
paralysis
Anaphylaxis Anaphylaxis none mild moderate severe life threatening
Osteonecrosis Osteonecrosis (avascular necrosis)
none asymptomatic and detected by imaging
only
symptomatic and interfering, but not
interfering with activities of daily living
symptomatic and interfering with activities
of daily living
symptomatic or disabling
Other toxicity: no yes (specify, and if possible, precise the NCI-grades: 0=normal; 1=mild; 2=moderate; 3=severe; 4=life-threatening)If case of SAE, please use the SAE-form
Abbreviations: EF = ejection fraction SF = shortening fraction LLN = lower normal limit UNL = upper normal limit TPN = total parenteral nutrition CHF = congestive hear failure
_____________________________ _______________ _______________________________ ____________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e p h y s i c i a n
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Acute toxicity during / after therapy elements of EURO-LB 02Surname (or initial): __________________________________ First name (or initial): _____________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Maximum toxicity during / after: Prephase I/a I/b M II/a II/b Begin of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy) End of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy)
Grade 0 1 2 3 4 not tested
Haematology Haemoglobin (g/l) normal for age 100 - < LLN 80 - < 100 65 - < 80 < 65
Thrombosis Thrombosis / embolism none - deep vein thrombosis,
not requiring anticoagulant
deep vein thrombosis, requiring anticoagulant
therapy
embolic event (including pulmonary embolism)
Neurological toxicityCentralneurotoxicity
none temporary lethargy somnolence < 50% of the time,
moderate disorientation
somnolence 50% of the time,
severe disorientation, hallucination
coma, seizures
Peripheralneurotoxicity
none paresthesia severe paresthesia and/or mild weakness
unbearable paresthesia, obvious deficits in motoric function
paralysis
Anaphylaxis Anaphylaxis none mild moderate severe life threatening
Osteonecrosis Osteonecrosis (avascular necrosis)
none asymptomatic and detected by imaging
only
symptomatic and interfering, but not
interfering with activities of daily living
symptomatic and interfering with activities
of daily living
symptomatic or disabling
Other toxicity: no yes (specify, and if possible, precise the NCI-grades: 0=normal; 1=mild; 2=moderate; 3=severe; 4=life-threatening)If case of SAE, please use the SAE-form
Abbreviations: EF = ejection fraction SF = shortening fraction LLN = lower normal limit UNL = upper normal limit TPN = total parenteral nutrition CHF = congestive hear failure
_____________________________ _______________ _______________________________ ____________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e p h y s i c i a n
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Acute toxicity during / after therapy elements of EURO-LB 02Surname (or initial): __________________________________ First name (or initial): _____________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Maximum toxicity during / after: Prephase I/a I/b M II/a II/b Begin of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy) End of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy)
Grade 0 1 2 3 4 not tested
Haematology Haemoglobin (g/l) normal for age 100 - < LLN 80 - < 100 65 - < 80 < 65
Thrombosis Thrombosis / embolism none - deep vein thrombosis,
not requiring anticoagulant
deep vein thrombosis, requiring anticoagulant
therapy
embolic event (including pulmonary embolism)
Neurological toxicityCentralneurotoxicity
none temporary lethargy somnolence < 50% of the time,
moderate disorientation
somnolence 50% of the time,
severe disorientation, hallucination
coma, seizures
Peripheralneurotoxicity
none paresthesia severe paresthesia and/or mild weakness
unbearable paresthesia, obvious deficits in motoric function
paralysis
Anaphylaxis Anaphylaxis none mild moderate severe life threatening
Osteonecrosis Osteonecrosis (avascular necrosis)
none asymptomatic and detected by imaging
only
symptomatic and interfering, but not
interfering with activities of daily living
symptomatic and interfering with activities
of daily living
symptomatic or disabling
Other toxicity: no yes (specify, and if possible, precise the NCI-grades: 0=normal; 1=mild; 2=moderate; 3=severe; 4=life-threatening)If case of SAE, please use the SAE-form
Abbreviations: EF = ejection fraction SF = shortening fraction LLN = lower normal limit UNL = upper normal limit TPN = total parenteral nutrition CHF = congestive hear failure
_____________________________ _______________ _______________________________ ____________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e p h y s i c i a n
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Acute toxicity during / after therapy elements of EURO-LB 02Surname (or initial): __________________________________ First name (or initial): _____________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Maximum toxicity during / after: Prephase I/a I/b M II/a II/b Begin of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy) End of therapy element: |__|__|.|__|__|.|__|__| (dd mm yy)
Grade 0 1 2 3 4 not tested
Haematology Haemoglobin (g/l) normal for age 100 - < LLN 80 - < 100 65 - < 80 < 65
Thrombosis Thrombosis / embolism none - deep vein thrombosis,
not requiring anticoagulant
deep vein thrombosis, requiring anticoagulant
therapy
embolic event (including pulmonary embolism)
Neurological toxicityCentralneurotoxicity
none temporary lethargy somnolence < 50% of the time,
moderate disorientation
somnolence 50% of the time,
severe disorientation, hallucination
coma, seizures
Peripheralneurotoxicity
none paresthesia severe paresthesia and/or mild weakness
unbearable paresthesia, obvious deficits in motoric function
paralysis
Anaphylaxis Anaphylaxis none mild moderate severe life threatening
Osteonecrosis Osteonecrosis (avascular necrosis)
none asymptomatic and detected by imaging
only
symptomatic and interfering, but not
interfering with activities of daily living
symptomatic and interfering with activities
of daily living
symptomatic or disabling
Other toxicity: no yes (specify, and if possible, precise the NCI-grades: 0=normal; 1=mild; 2=moderate; 3=severe; 4=life-threatening)If case of SAE, please use the SAE-form
Abbreviations: EF = ejection fraction SF = shortening fraction LLN = lower normal limit UNL = upper normal limit TPN = total parenteral nutrition CHF = congestive hear failure
_____________________________ _______________ _______________________________ ____________________ Hospital-Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e p h y s i c i a n
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Eventsshould be sent at least two weeks after occurrence of any event
Surname (or initial): ____________________________________ First name (or initial): ____________________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Non-responder at day 33 no yes less than 35% regression of tumour volume at day 33 no yes
persistence of 5% blasts in bone marrow at day 33 no yes persistence of blasts in CSF at day 33 no yes
Progression no yes, at |__|__|.|__|__|.|__|__| (dd mm yy)
Localisation(s) of progression: bone marrow no yes
CNS no yes
testes no yes
reappearance or increase of residuals no yes:_______________________________________________
appearance of new location(s) no yes:_______________________________________________
Therapy of progression planned/done? no yes:_______________________________________________
Second Malignancy no yes, at |__|__|.|__|__|.|__|__| (dd mm yy)
Diagnosis: AML MDS other:______________________________________________________________________
Therapy after diagnosis of second malignancy no yes: _________________________________________________________________________________________________________
Late Event no yes, at |__|__|.|__|__|.|__|__| (dd mm yy) (malignancy more than 3 years after diagnosis of T-LBL; no differentiation between progression and second malignancy possible)
Therapy after diagnosis of Late Event no yes: ________________________________________________________________________________________________________
Patient deceased no yes, at |__|__|.|__|__|.|__|__| (dd mm yy)
Autopsy: no yes
Reason for death: caused by lymphoma
caused by therapy complications
caused by late effect of lymphoma
caused by late effect of therapy
caused by second malignancy
caused by late event
caused by other illness: _____________________________________________________________________________________
caused by other reasons:____________________________________________________________________________________
Remarks:
__________________________ ______________ __________________________________ ______________________ Hospital Stamp Date (dd mm yy) Name (in block letters) Signature
responsib le phys ic ian
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Severe Adverse Events (SAE) Please send a Fax to the National Study Centre within 48 hours.
Surname (or initial): ____________________________________ First name (or initial): ____________________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__|(if known)
Reasons for SAE Report Therapy associated death please fill in the "Event" form and send it to the responsible data centre no yes Permanent handicap/damage in consequence no yes SAE which impair further therapy according to the Protocol EURO-LB 02 or make it impossible no yes Life threatening SAE no yes Unexpected, severe side effects, which can not be documented on the toxicity form no yes
NCI-CTC toxicity grading of SAE: 1 2 3 4 unknown / not to arrange
Beginning resp. detection of the SAE: at |__|__|.|__|__|.|__|__| (dd mm yy)
During/after therapy element: Prephase I/a I/b M II/a II/b Maintenance therapy after end of therapy Other, please describe:__________________________________________________________________________________________
Please describe the event and the taken measures: (Symptoms, localisation, laboratory reports, diagnostics, duration, therapy and course; if necessary please attach additional sheet) _____________________________________________________________________________________________________________________
Medication at the occurrence of the SAE Relationship between medication and event N° Medicament Daily dosage Application Dates of therapy
(from/to) n
ot re
late
d
unl
ikel
y
pos
sibl
e
pro
babl
e
rela
ted
insu
ffici
ent
dat
a to
a
sses
s
1. 2. 3. 4. 5. 6. 7. 8. 9.
10. Is there a relationship possible between the SAE and medication administered before the SAE occurred? no yes, ___________________________
Has (have) one (or several) treatment(s) been stopped? no yes, N°: ______________________
Did reaction abate after stopping the treatment(s)? no yes, N°: ______________________
Has (have) one (or several) treatment(s) been reintroduced? no yes, N°: ______________________
Did reaction reappear after reintroduction? no yes, N°: ______________________
Was (were) the dosage(s) changed? no yes, N°: ______________________
According to your opinion, SAE is related to: Disease aggravation, which the patient was in the trial for Other concomitant disease(s) Treatment according to Protocol EURO-LB 02 Other concomitant treatment(s) Other known or suspected cause(s), please comment: ___________________________________________________________
Outcome Ongoing Recovered without after-effects Recovered with after-effects Death due to the SAE Death unconnected with the SAE
Date of recovering or of death: |__|__|.|__|__|.|__|__| (dd mm yy) or not applicable (still ongoing)
______________________ ___________________________ _______________ ______________________________ Signature Name (in block letters) Date (dd mm yy) Hospital Stamp
responsib le phys ic ian
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Late EffectsSurname (or initial): ____________________________________ First name (or initial): _____________________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Late effect(s): no yes Date of 1st occurrence(dd mm yy)
Specification of late effect(s)
Cardiovascular system |__|__|.|__|__|.|__|__| ___________________________________
* Grade of osteonecrosis: 0 = no osteonecrosis 1 = asymptomatic and detected by imaging only
2 = symptomatic and interfering, but not interfering with activities of daily living 3 = symptomatic and interfering with activities of daily living 4 = symptomatic or disabling
In case of Cardiac Toxicity: Grade 0 1 2 3 4 not tested
Cardiac function normal asymptomatic decline of resting EF of 10% but <20%
of baseline value; SF 24% but <30%
asymptomatic but resting EF below LLN for laboratory or
decline of resting EF 20% of baseline value;
SF <24%
mild CHF, therapeutically compensated
severe or refractory CHF or
requiring intubation
Arrhythmia none asymptomatic, not requiring treatment
recurr. / persist., but not requiring treatment
requiring treatment
hypotension, ventr. arrhythmia,
defibrillation
Other cardiac toxicity: no yes, specify: __________________________________________________
Remarks:
______________________ ______________ __________________________________ ______________________ Hospital Stamp Date (dd mm yy) Name (in block letters) Signature
responsib le phys ic ian
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Kinetics of Treatment Response The "Kinetics of Treatment Response" form should be sent after Induction Phase I/a
Surname (or initial): ____________________________ First name (or initial): _____________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Tumour volume:
CT
day 0 (initial staging)
Volume: not evaluated |__|__|__|__| ml
evaluated by volume calculation by measurement with 3D software
DICOM data available? no yes
day 8 (after beginning of cytoreductive prephase)
Volume: not evaluated |__|__|__|__| ml
evaluated by volume calculation by measurement with 3D software
DICOM data available? no yes
day 15 (after beginning of cytoreductive prephase)
Volume: not evaluated |__|__|__|__| ml
evaluated by volume calculation by measurement with 3D software
DICOM data available? no yes
day 33 *(after beginning of cytoreductive prephase)
Volume: not evaluated |__|__|__|__| ml
evaluated by volume calculation by measurement with 3D software
DICOM data available? no yes
*) At day 33 CT-scan only, if the tumour regression at day 15 was less than 35%.
Volume calculation:
Tumour volume [ml] = Axial Dim1 [cm] x Axial Dim2 [cm] x Height [cm] x 0,52
Remarks:
__________________________ ______________ __________________________________ ______________________ Hospital Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e p h y s i c i a n
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Histopathological and Immunohistochemical Review (page 1/2)(to be filled in by the reference pathologist and to be sent with a written report to the responsible data centre)
Surname (or initial): ______________________________ First name (or initial): ___________________________
Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy) Registration number: |__|__|__|__|__| (if known)
Site / origin of the material:
a) Material with infiltration of lymphoma: ____________________________________________________________
b) Material without infiltration of lymphoma: _________________________________________________________
Organisational Aspects
Histology number of local pathology: |__|__|__|__|__|__|__|__|__|__|__|__|__|__|__|__|
Histology number of reference pathology: |__|__|__|__|__|__|__|__|__|__|__|__|__|__|__|__|
Name of the reviewer: _________________________________________________________________________
Date of review: |__|__|.|__|__|.|__|__| (dd mm yy)
Sufficient / representative material? no yes
Diagnosis
B precursor lymphoblastic lymphoma (WHO: precursor B lymphoblastic lymphoma; ICD-O 9728/3); please specify the subtype:
pro-B (pre-pre B) common pre-B no subtyping possible
T lymphoblastic lymphoma (WHO: precursor T lymphoblastic lymphoma; ICD-O 9729/3); please specify the subtype:
T-I (pro-T) T II (pre-T) T III (cortical-T) T-IV (mature-T) no subtyping possible
Typical morphology of lymphoblastic lymphoma? yes no, please specify:_________________________________________________________________
Version: Nov. 2002
Therapy Study EURO-LB 02 Space for the address of the responsible data centre
Histopathological and Immunohistochemical Review (page 2/2)(to be filled in by the reference pathologist and to be sent with a written report to the responsible data centre)
Name (or initials): _______________________________________ Date of birth: |__|__|.|__|__|.|__|__| (dd mm yy)
Immunhistochemie: "n.i.": not interpretable " / n.d.": not done / "-" : negative"+": few positive cells / "++": significant number of positive cells / "+++": positivity of almost all the cells
Other Antibodies (please give name(s) and result(s)): _____________________________: - + ++ +++ n.i. n.d. _____________________________: - + ++ +++ n.i. n.d. _____________________________: - + ++ +++ n.i. n.d.
Other Characteristics / Remarks:
_______________________ ________________ ____________________________ _______________________Hospital Stamp Date (dd mm yy) Name (in block letters) Signature
r e s p o n s i b l e s c i e n t i s t
EURO-LB 02 61
Version Nov. 2002
Therapy schema of High-Dose Methotrexate Protocol M starts 2 weeks after completion of Protocol I and is composed of 6-MP over 56 days and 4 courses of high-dose MTX (5g/m2 as 24 h infusion day 8, 22, 36 and 50).
Name:_______________________________ Date of Birth:_______________________
Requirements: Good general condition without serious infections, renal function within normal age-adapted limits, GOT/GPT ≤ 5xUNL, bilirubin normal, WBC ≥ 1.5 x 109/l, platelets ≥ 50 x 109/lTherapy management: Due to MTX-metabolism interactions Co-trimoxazole should not be given for at least 6 days prior to the beginning of the MTX-therapy and it should be resumed only after completion of the MTX-therapy. Days 1 – 56 _______ mg 6-Mercaptopurine p.o. (25 mg/m2/d), in the evening (_______-_______) (1 tbl. Puri-Nethol contains 50 mg) _______ mg/d x 56 d = _______mg cumulative dose _______ mg cumulative dose :50 mg = _______ tbl. Puri-Nethol distributed over 56 days Therapy schema of high-dose Methotrexate: Day 1 Pre-Hydration(_______) _______ ml NaHCO3 8.4% (2 ml/kg) in _______ ml aqua dest. (2 ml/kg) infusion over 1 h, then 500 ml NaCl 0.45%:Gluc 5%
+ 40 ml NaHCO3 8.4%+ 10 ml KCl 7.45%
over at least 2 hrs, in order to achieve urine pH � 7 and urine output � 100 ml/m²/h Day 1 (1400 h) if urine pH > 7.0(_______) _______ mg Methotrexate 500 mg/m2 initially as infusion over 30 min _______ mg Methotrexate 4.5 g/m2 as infusion over 23 ½ hours + _______ ml NaCl 0.45%:Gluc 5% (3 000 ml/m2/d) + _______ ml NaHCO3 8.4% (180 ml/m2/d) + _______ ml KCl 7.45% (90 ml/m2/d) _______ ml/hDay 1 (1600 h) _______Methotrexate i.th. in age-adapted dose:LP! 2 hours after start of MTX years: <1 <2 <3 ≥3 dose (mg i.th.): 6 8 10 12 (lowered head, prone position for 2 hrs) Days 1-3 Fluid balance every 12 hours, urine pH (test strips) at every miction(_______-_______) if urine pH < 7.0 _______ NaHCO3 8.4% (2 ml/kg) in _______ aqua dest. (2 ml/kg) as infusion over 30 min. if input > output + 400 ml/m2/12 hrs:_______ Furosemide i.v. (0.5 mg/kg, maximum 20 mg SD) Days 2+3 Hydration(_______-_______) _______ ml NaCl 0.45%:Gluc 5% (3 000 ml/m2/d) _______ ml NaHCO3 8.4% (180 ml/m2/d) _______ ml KCl 7.45% (90 ml/m2/d)Days 2+3 Folinic Acid Rescue (Leucovorin)(_______-_______) _______ mg LCV i.v. (15 mg/m2/SD) at hour 42, 48 and 54
•= MTX-level measurement: 24, 42 and 48 hrs after start of MTX-infusion •= if MTX24 > 150 μmol/l, MTX42 > 1 μmol/l or MTX48 > 0.4 μmol/l
then forced diuresis, MTX-levels every 6 hrs and LCV as described below
