Status:
COMPLETED
ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Fondation ARC
Conditions:
Lymphoma, Large-Cell, Diffuse
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate r...
Eligibility Criteria
Inclusion
- Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
- Aged 18 to 60 years
- Non previously treated
- With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
- Negative HIV, HBV and HCV serologies (except vaccination)
- With a minimum life expectancy of 3 months
- Having previously signed a written informed consent
Exclusion
- Any history of treated or non-treated indolent lymphoma.
- T-cell lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Any Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Serious active disease (according to the investigator's decision).
- Poor bone marrow reserve as defined by neutrophils \<1.5G/l or platelets\<100G/l, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Childbearing woman.
- Patients previously treated with an organ transplantation.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00169130
Start Date
October 1 1999
Last Update
July 13 2007
Active Locations (5)
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1
Service d'Hematologie
Mont-Godinne, Belgium
2
Hôpital Henri Mondor
Créteil, France
3
Hôpital Saint Louis
Paris, France, 75010
4
Centre Hospitalier Lyon Sud
Pierre-Bénite, France