Trial | NCT00169130  Report issue

Title

ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation 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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
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.
Study Started
Oct 31
1999
Last Update
Jul 13
2007
Estimate

Drug doxorubicin

Drug cyclophosphamide

Procedure Autologous stem cell transplantation

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.
No Results Posted