ID

28334

Description

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Keywords

Versions (2)
  1. 11/30/17 11/30/17 -
  2. 1/4/18 1/4/18 -
Copyright Holder

Prof. Dr. med. Georg Heß

Uploaded on

January 4, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

English

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 forms  
Admininstrative data
Description

Admininstrative data

Alias
UMLS CUI-1
C1320722
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Patients aged >=18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Trial Protocol Version 1.0: 2. CD20 positive disease
Description

Trial Protocol Version 2.0: Criterion 2 removed.

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3888518
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)
Description

Diagnosis lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0024299
4. Relapsed disease
Description

Relapsed disease

Data type

boolean

Alias
UMLS CUI [1]
C0277556
5. ECOG performance status =< 2, unless tumor associated
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
Description

LVEF

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Trial protocol Version 2.0: 6. Adequate cardiac reserve
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C2347957
7. No curative option available
Description

cure no

Data type

boolean

Alias
UMLS CUI [1,1]
C1880198
UMLS CUI [1,2]
C1298908
8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
Description

tumor mass

Data type

boolean

Alias
UMLS CUI [1]
C3273930
9. Signed informed consent
Description

informed consent signed

Data type

boolean

Alias
UMLS CUI [1]
C0742766
10. Adequate bone marrow reserve / hepatic and renal function
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C2347957
UMLS CUI [1,3]
C0232741
UMLS CUI [1,4]
C0232804
11. No active Hepatitis B or C or HIV-infection
Description

Hepatitis B Hepatitis C HIV-infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0019196
UMLS CUI [1,3]
C0019693
12. Measured or calculated creatinine clearance > 30 ml/min
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0812399
13. Fresh tumor biopsy or archived tissue available
Description

Fresh tumor biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C2827486
14. Ability of patient to understand nature, importance and individual consequences of clinical trial
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0232970
16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
Description

contraception male patients

Data type

boolean

Alias
UMLS CUI [1]
C0086580
Back to the top of the page

Similar models

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Admininstrative data
C1320722 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
1. Patients aged >=18 years
boolean
C0001779 (UMLS CUI [1])
disease CD20 positive
Item
Trial Protocol Version 1.0: 2. CD20 positive disease
boolean
C0012634 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Diagnosis 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
C0011900 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Relapsed disease
Item
4. Relapsed disease
boolean
C0277556 (UMLS CUI [1])
ECOG performance status
Item
5. ECOG performance status =< 2, unless tumor associated
boolean
C1520224 (UMLS CUI [1])
LVEF
Item
Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
boolean
C0428772 (UMLS CUI [1])
cardiac reserve
Item
Trial protocol Version 2.0: 6. Adequate cardiac reserve
boolean
C0232164 (UMLS CUI [1,1])
C2347957 (UMLS CUI [1,2])
cure no
Item
7. No curative option available
boolean
C1880198 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
tumor mass
Item
8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
boolean
C3273930 (UMLS CUI [1])
informed consent signed
Item
9. Signed informed consent
boolean
C0742766 (UMLS CUI [1])
bone marrow hepatic and renal function
Item
10. Adequate bone marrow reserve / hepatic and renal function
boolean
C0005953 (UMLS CUI [1,1])
C2347957 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,3])
C0232804 (UMLS CUI [1,4])
Hepatitis B Hepatitis C HIV-infection
Item
11. No active Hepatitis B or C or HIV-infection
boolean
C0019163 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
creatinine clearance
Item
12. Measured or calculated creatinine clearance > 30 ml/min
boolean
C0812399 (UMLS CUI [1])
Fresh tumor biopsy
Item
13. Fresh tumor biopsy or archived tissue available
boolean
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2827486 (UMLS CUI [1,3])
compliance
Item
14. Ability of patient to understand nature, importance and individual consequences of clinical trial
boolean
C1321605 (UMLS CUI [1])
childbearing potential post-menopausal
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
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
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
C0086580 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial