Randomized Study for Patients With Follicular Lymphoma Needing Treatment
NCT ID: NCT00140569
Last Updated: 2005-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
1994-01-31
2004-01-31
Brief Summary
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* 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
Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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CHVP + interferon
fludarabine
CHOP + TBI and autotransplant
Eligibility Criteria
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Inclusion Criteria
* 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
* transformation into large cell lymphoma
* previous treatment
* localized stage without criteria of large tumor mass
* patients HIV+
18 Years
ALL
No
Sponsors
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Lymphoma Study Association
OTHER
Principal Investigators
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Bertrand Coiffier, MD
Role: STUDY_CHAIR
Hospices Civils de Lyon
Catherine Sebban, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Groupe d'atude des lymphome de l'adulte
Yvoir, , Belgium
Hôpital Henri Mondor
Créteil, , France
Centre Léon Bérard
Lyon, , France
Hôpital Saint Louis
Paris, , France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Centre Hospitalier Robert Debré
Reims, , France
Centre Henri Becquerel
Rouen, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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. doi: 10.1023/a:1008347425795.
Related Links
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Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)
Other Identifiers
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Gelf-94
Identifier Type: -
Identifier Source: org_study_id