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

Primary Purpose

Lymphoma, Large-Cell, Diffuse

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
doxorubicin
cyclophosphamide
Autologous stem cell transplantation
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large-Cell, Diffuse focused on measuring lymphoma, autologous stem cell transplant, chemotherapy, BCL2

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Service d'Hematologie
  • Hôpital Henri Mondor
  • Hôpital Saint Louis
  • Centre Hospitalier Lyon Sud
  • Centre Henri Becquerel

Outcomes

Primary Outcome Measures

Event free survival.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
July 12, 2007
Sponsor
Lymphoma Study Association
Collaborators
Fondation ARC
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1. Study Identification

Unique Protocol Identification Number
NCT00169130
Brief Title
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

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lymphoma Study Association
Collaborators
Fondation ARC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large-Cell, Diffuse
Keywords
lymphoma, autologous stem cell transplant, chemotherapy, BCL2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Procedure
Intervention Name(s)
Autologous stem cell transplantation
Primary Outcome Measure Information:
Title
Event free survival.
Secondary Outcome Measure Information:
Title
Complete response rate at the end of treatment.
Title
Disease-free survival for complete responders.
Title
Overall survival.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Morel, MD
Organizational Affiliation
Centre Hospitalier Schaffner, Lens FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hematologie
City
Mont-Godinne
Country
Belgium
Facility Name
Hôpital Henri Mondor
City
Creteil
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.gela.org
Description
Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In French)

Learn more about this trial

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

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