Clinical trial NCT00140569: Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Official title: Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Follicular Lymphoma
Keywords: follicular lymphoma
CHVP + interferon
fludarabine
autotransplant
Lead sponsor: Lymphoma Study Association
Sponsor class: OTHER
First posted: 2005-09-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

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 outcomes:
measure: Progression-free survival
Secondary outcomes:
measure: Overall survival
measure: Toxicity
measure: Response rates
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: Groupe d'atude des lymphome de l'adulte
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre-Bénite cedex
country: France
facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud
city: Reims
country: France
facility: Centre Hospitalier Robert Debré
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Hospices Civils de Lyon
name: Bertrand Coiffier, MD
role: STUDY_CHAIR
affiliation: Centre Leon Berard
name: Catherine Sebban, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.