Randomized Study for Patients With Follicular Lymphoma Needing Treatment - Full Text View

Sponsored by:	Groupe d'Etudes de Lymphomes de L'Adulte
Information provided by:	Groupe d'Etudes de Lymphomes de L'Adulte
ClinicalTrials.gov Identifier:	NCT00140569

Purpose

2 parallel studies.

For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

Condition	Intervention	Phase
Follicular Lymphoma	Procedure: CHVP + interferon Drug: fludarabine Procedure: CHOP + TBI and autotransplant	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Fludarabine Fludarabine monophosphate Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Study for Patients With Follicular Lymphoma Needing Treatment

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

Primary Outcome Measures:

Progression-free survival

Secondary Outcome Measures:

Overall survival
Toxicity
Response rates

Estimated Enrollment:	400
Study Start Date:	January 1994
Estimated Study Completion Date:	January 2004

Detailed Description:

2 parallel studies.

For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)

Exclusion Criteria:

contra-indication to anthracycline or interferon
transformation into large cell lymphoma
previous treatment
localized stage without criteria of large tumor mass
patients HIV+

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140569

Locations

Belgium
Groupe d'atude des lymphome de l'adulte
Yvoir, Belgium
France
Centre Henri Becquerel
Rouen, France, 76038
Centre Hospitalier Robert Debré
Reims, France, 51092
Hôpital Henri Mondor
Créteil, France, 94010
Centre Léon Bérard
Lyon, France, 69008
Institut Gustave Roussy
Villejuif, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495
Hôpital Saint Louis
Paris, France, 75010

Sponsors and Collaborators

Groupe d'Etudes de Lymphomes de L'Adulte

Investigators

Study Chair:	Bertrand Coiffier, MD	Hospices Civils de Lyon
Principal Investigator:	Catherine Sebban, MD	Centre Léon Bérard

More Information

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

Publications of Results:

Coiffier B, Neidhardt-Berard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Peaud PY, Pico JL, Janvier M, Solal-Celigny P, Brousse N. Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: a GELA study. Groupe d'Etudes des Lymphomes de l'Adulte. Ann Oncol. 1999 Oct;10(10):1191-7.

Study ID Numbers:	Gelf-94
Study First Received:	August 31, 2005
Last Updated:	August 31, 2005
ClinicalTrials.gov Identifier:	NCT00140569
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe d'Etudes de Lymphomes de L'Adulte:

follicular lymphoma
CHVP + interferon
fludarabine
autotransplant

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Interferons
Lymphoma, Follicular
Fludarabine

Fludarabine monophosphate
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors

Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on January 13, 2009