Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Lymphoma Study Association (LYSA)

Status and phase

Completed

Phase 3

Conditions

Follicular Lymphoma

Treatments

Drug: fludarabine

Procedure: CHVP + interferon

Procedure: CHOP + TBI and autotransplant

Study type

Interventional

Funder types

Other

Identifiers

Gelf-94

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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