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Randomized Study for Patients With Follicular Lymphoma Needing Treatment


Phase 3
18 Years
N/A
Not Enrolling
Both
Follicular Lymphoma

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Trial Information

Randomized Study for Patients With Follicular Lymphoma Needing Treatment


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


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+

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Principal Investigator

Bertrand Coiffier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Gelf-94

NCT ID:

NCT00140569

Start Date:

January 1994

Completion Date:

January 2004

Related Keywords:

  • Follicular Lymphoma
  • follicular lymphoma
  • CHVP + interferon
  • fludarabine
  • autotransplant
  • Lymphoma
  • Lymphoma, Follicular

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