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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphoma, Large-Cell, Diffuse

Intervention / Treatment
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* Drug: doxorubicin
* Drug: cyclophosphamide
* Procedure: Autologous stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: doxorubicin|nan|
|Drug: cyclophosphamide|nan|
|Procedure: Autologous stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate at the end of treatment. |  |  | 
| Disease-free survival for complete responders. |  |  | 
| Overall survival. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma, autologous stem cell transplant, chemotherapy, BCL2