CompletedInterventionalPhase 3Updated Nov 14, 2018
Randomized Study for Patients With Follicular Lymphoma Needing Treatment | NCT00140569 | Trialant
CompletedInterventionalPhase 3Updated Sep 1, 2005
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
ClinicalTrials.gov ID
NCT00140569
Lead Sponsor
Lymphoma Study AssociationOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
400
Last Update Posted
Sep 1, 2005Estimated
Start Date
Jan 1994
Completion Date
Jan 2004
Official Title
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Brief Summary
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
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
Follicular Lymphoma
CHVP + interferon
fludarabine
CHOP + TBI and autotransplant
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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+
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Groupe d'atude des lymphome de l'adulte
Yvoir, Belgium
Hôpital Henri Mondor
Créteil, 94010, France
Centre Léon Bérard
Lyon, 69008, France
Hôpital Saint Louis
Paris, 75010, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud