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

Lymphoma Study Association (LYSA)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Lymphoma, Large-Cell, Diffuse

Treatments

Drug: doxorubicin

Drug: cyclophosphamide

Procedure: Autologous stem cell transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00169130

LNH98-B2

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.