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ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
This study has been completed.
Sponsors and Collaborators: Groupe d'Etudes de Lymphomes de L'Adulte
Association pour la Recherche sur le Cancer (ARC), Villejuif, France.
Information provided by: Groupe d'Etudes de Lymphomes de L'Adulte
ClinicalTrials.gov Identifier: NCT00169130
  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 II
Phase III

MedlinePlus related topics: Lymphoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
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

Further study details as provided by Groupe d'Etudes de Lymphomes de L'Adulte:

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169130

Locations
Belgium
Service d'Hematologie
Mont-Godinne, Belgium
France
Hôpital Saint Louis
Paris, France, 75010
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Henri Becquerel
Rouen, France, 76000
Hôpital Henri Mondor
Creteil, France
Sponsors and Collaborators
Groupe d'Etudes de Lymphomes de L'Adulte
Association pour la Recherche sur le Cancer (ARC), Villejuif, France.
Investigators
Principal Investigator: Pierre Morel, MD Centre Hospitalier Schaffner, Lens FRANCE
  More Information

Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In French)  This link exits the ClinicalTrials.gov site

Study ID Numbers: LNH98-B2
Study First Received: September 12, 2005
Last Updated: July 12, 2007
ClinicalTrials.gov Identifier: NCT00169130  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe d'Etudes de Lymphomes de L'Adulte:
lymphoma
autologous stem cell transplant
chemotherapy
BCL2

Study placed in the following topic categories:
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
B-cell lymphomas
Cyclophosphamide
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Doxorubicin

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 13, 2009