Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).

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

Details

• Lead Sponsor: Lymphoma Study Association
• Collaborator: Amgen
• Treatments: Bleomycin; Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vindesine

Criteria

Inclusion Criteria:

• Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).

• Age >18 and < 61 years, eligible for transplant.

• Patient not previously treated.

• With at least two prognostic factors of the Aa-IPI.

• With a minimum life expectancy of 3 months.

• Creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma.

• Neutrophils > 1.5 G/l and platelets > 100 G/l, unless if patient has a bone marrow infiltration.

• Negative HIV, HBV and HCV serologies 4 weeks (except after vaccination).

• Having previously signed a written informed consent.

Exclusion Criteria:

• Any other histological type of lymphoma.

• Any history of treated or non-treated indolent lymphoma.

• Central nervous system or meningeal involvement by lymphoma.

• Contra-indication to any drug contained in the chemotherapy regimens.

• Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.

• Any serious active disease (according to the investigator's decision).

• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.

• Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception.

• Adult patient under tutelage.