FindTrial
Sign In

Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00140569
Enrollment
400
Registered
2005-09-01
Start date
1994-01-31
Completion date
2004-01-31
Last updated
2005-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Keywords

follicular lymphoma, CHVP + interferon, fludarabine, autotransplant

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

Interventions

PROCEDURECHVP + interferon
DRUGfludarabine
PROCEDURECHOP + TBI and autotransplant

Sponsors

Lymphoma Study Association
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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+

Design outcomes

Primary

MeasureTime frame
Progression-free survival—

Secondary

MeasureTime frame
Overall survival—
Toxicity—
Response rates—

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026