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

Phase 2

Completed

• Conditions: Lymphoma, Large-Cell, Diffuse

• Registration Number: NCT00169130
• Lead Sponsor: Lymphoma Study Association

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 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-12
• Last Update Posted: 2007-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Event free survival.

Secondary Outcome Measures

Name	Time	Method
Complete response rate at the end of treatment.
Disease-free survival for complete responders.
Overall survival.

Trial Locations

Locations (5)

Hôpital Saint Louis; 🇫🇷 Paris, France

Service d'Hematologie; 🇧🇪 Mont-Godinne, Belgium

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

Centre Henri Becquerel; 🇫🇷 Rouen, France