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Completed

NCT Number: NCT00140569

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

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Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Groupe d'atude des lymphome de l'adulte, Yvoir, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+

Treatment and study plan

CHVP + interferon

Procedure

Fludarabine

Drug

CHOP + TBI and autotransplant

Procedure

Primary outcomes

  1. Progression-free survival

Secondary outcomes

  1. Overall survival

  2. Toxicity

  3. Response rates

Sponsors and collaborators

Lead sponsor

Lymphoma Study Association

Other

Registry information

Important dates

Study start
1994
Study completion
2004
First posted
Sep 1, 2005
Registry last updated
Sep 1, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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