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Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Primary Purpose

Follicular Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CHVP + interferon
fludarabine
CHOP + TBI and autotransplant
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring follicular lymphoma, CHVP + interferon, fludarabine, autotransplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: contra-indication to anthracycline or interferon transformation into large cell lymphoma previous treatment localized stage without criteria of large tumor mass patients HIV+

Sites / Locations

  • Groupe d'atude des lymphome de l'adulte
  • Hôpital Henri Mondor
  • Centre Léon Bérard
  • Hôpital Saint Louis
  • Service d'Hématologie - Centre Hospitalier Lyon-Sud
  • Centre Hospitalier Robert Debré
  • Centre Henri Becquerel
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Toxicity
Response rates

Full Information

First Posted
August 31, 2005
Last Updated
August 31, 2005
Sponsor
Lymphoma Study Association
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1. Study Identification

Unique Protocol Identification Number
NCT00140569
Brief Title
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Official Title
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
January 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lymphoma Study Association

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
follicular lymphoma, CHVP + interferon, fludarabine, autotransplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
CHVP + interferon
Intervention Type
Drug
Intervention Name(s)
fludarabine
Intervention Type
Procedure
Intervention Name(s)
CHOP + TBI and autotransplant
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Toxicity
Title
Response rates

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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+
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Coiffier, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Catherine Sebban, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe d'atude des lymphome de l'adulte
City
Yvoir
Country
Belgium
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Service d'Hématologie - Centre Hospitalier Lyon-Sud
City
Pierre-Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10586336
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.
Results Reference
result
Links:
URL
http://www.gela.org
Description
Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)

Learn more about this trial

Randomized Study for Patients With Follicular Lymphoma Needing Treatment

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