ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.

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

Details

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

Criteria

Inclusion Criteria:

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

• Age from 18 to 65 years.

• Patient not previously treated.

• Ann Arbor stage I or II.

• ECOG performance status < 2.

• Normal LDH.

• 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. vAny history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in lymph node may be included.

• Central nervous system or meningeal involvement by lymphoma.

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

• Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level).

• Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l.

• 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

• Adult patient under tutelage.