ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Collaborator: Fondation ARC
• Treatments: Cyclophosphamide; Doxorubicin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.