Clinical trial NCT00169130: ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lymphoma, Large-Cell, Diffuse
Keywords: lymphoma
autologous stem cell transplant
chemotherapy
BCL2
Lead sponsor: Lymphoma Study Association
Sponsor class: OTHER
Collaborators: name: Fondation ARC
First posted: 2005-09-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Event free survival.
Secondary outcomes:
measure: Complete response rate at the end of treatment.
measure: Disease-free survival for complete responders.
measure: Overall survival.
Other outcomes:
Locations:
city: Mont-Godinne
country: Belgium
facility: Service d'Hematologie
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Hospitalier Schaffner, Lens FRANCE
name: Pierre Morel, MD
role: PRINCIPAL_INVESTIGATOR
References: