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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169130
First Posted: September 15, 2005
Last Update Posted: July 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondation ARC
Information provided by:
Lymphoma Study Association
  Purpose
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.

Condition Intervention Phase
Lymphoma, Large-Cell, Diffuse Drug: doxorubicin Drug: cyclophosphamide Procedure: Autologous stem cell transplantation Phase 2 Phase 3

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

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

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.

Estimated Enrollment: 300
Study Start Date: October 1999
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169130


Locations
Belgium
Service d'Hematologie
Mont-Godinne, Belgium
France
Hôpital Henri Mondor
Creteil, France
Hôpital Saint Louis
Paris, France, 75010
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Henri Becquerel
Rouen, France, 76000
Sponsors and Collaborators
Lymphoma Study Association
Fondation ARC
Investigators
Principal Investigator: Pierre Morel, MD Centre Hospitalier Schaffner, Lens FRANCE
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00169130     History of Changes
Other Study ID Numbers: LNH98-B2
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: July 13, 2007
Last Verified: July 2007

Keywords provided by Lymphoma Study Association:
lymphoma
autologous stem cell transplant
chemotherapy
BCL2

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors