Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Admininstrative data
Beskrivning

Admininstrative data

Subject ID
Beskrivning

Subject ID

Datatyp

text

Inclusion Criteria
Beskrivning

Inclusion Criteria

1. Patients aged >=18 years
Beskrivning

Age

Datatyp

boolean

Trial Protocol Version 1.0: 2. CD20 positive disease
Beskrivning

Trial Protocol Version 2.0: Criterion 2 removed.

Datatyp

boolean

3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
Beskrivning

Diagnosis of lymphoma

Datatyp

boolean

4. Relapsed disease
Beskrivning

Relapsed disease

Datatyp

boolean

5. ECOG performance status =< 2, unless tumor associated
Beskrivning

ECOG performance status

Datatyp

boolean

Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
Beskrivning

LVEF

Datatyp

boolean

Trial protocol Version 2.0: 6. Adequate cardiac reserve
Beskrivning

Serum troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease

Datatyp

boolean

7. No curative option available
Beskrivning

No curative option available

Datatyp

boolean

8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
Beskrivning

tumor mass

Datatyp

boolean

9. Signed informed consent
Beskrivning

Signed informed consent

Datatyp

boolean

10. Adequate bone marrow reserve / hepatic and renal function
Beskrivning

Adequate bone marrow reserve: - Platelets of at least 100.000/μl (in case of extensive BM-Infiltration 75.000/μl may be acceptable after discussion with the coordinating investigator); - absolute neutrophil count of at least 1000/μl . Adequate hepatic and renal function: - ALT < 2.5 x upper limit of normal (ULN); - AST < 2.5 x ULN; - total Bilirubin < 1.5 x ULN.

Datatyp

boolean

11. No active Hepatitis B or C or HIV-infection
Beskrivning

Infections

Datatyp

boolean

12. Measured or calculated creatinine clearance > 30 ml/min
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creatinine clearance

Datatyp

boolean

13. Fresh tumor biopsy or archived tissue available
Beskrivning

Fresh tumor biopsy or archived tissue

Datatyp

boolean

14. Ability of patient to understand nature, importance and individual consequences of clinical trial
Beskrivning

Understanding patient

Datatyp

boolean

15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
Beskrivning

Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms /intrauterine devices (IUP) with spermicide.

Datatyp

boolean

16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
Beskrivning

contraception male patients

Datatyp

boolean

Similar models

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Admininstrative data
Subject ID
Item
Subject ID
text
Item Group
Inclusion Criteria
Age
Item
1. Patients aged >=18 years
boolean
CD20 positive disease
Item
Trial Protocol Version 1.0: 2. CD20 positive disease
boolean
Diagnosis of lymphoma
Item
3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
boolean
Relapsed disease
Item
4. Relapsed disease
boolean
ECOG performance status
Item
5. ECOG performance status =< 2, unless tumor associated
boolean
LVEF
Item
Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
boolean
Adequate cardiac reserve
Item
Trial protocol Version 2.0: 6. Adequate cardiac reserve
boolean
No curative option available
Item
7. No curative option available
boolean
tumor mass
Item
8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
boolean
Signed informed consent
Item
9. Signed informed consent
boolean
bone marrow reserve hepatic and renal function
Item
10. Adequate bone marrow reserve / hepatic and renal function
boolean
Infections
Item
11. No active Hepatitis B or C or HIV-infection
boolean
creatinine clearance
Item
12. Measured or calculated creatinine clearance > 30 ml/min
boolean
Fresh tumor biopsy or archived tissue
Item
13. Fresh tumor biopsy or archived tissue available
boolean
Understanding patient
Item
14. Ability of patient to understand nature, importance and individual consequences of clinical trial
boolean
Pregnancy ruled out
Item
15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
boolean
contraception male patients
Item
16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
boolean