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Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rituximab
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring lymphoma, follicular, B-cell, rituximab, interferon

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months Patients previously untreated. Patients with at least one of the following symptoms requiring initiation of treatment: Bulky disease at study entry according to the Groupe d'Etudes Lymphomes Folliculare (GELF) criteria: nodal or extranodal mass > 7cm in its greater diameter B symptoms Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 1 Elevated serum lactate dehydrogenase (LDH) or beta2-microglobulin Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) Symptomatic splenic enlargement Compressive syndrome Pleural/peritoneal effusion Age must be > 18 years and less than 76 years Having previously signed a written informed consent form. Exclusion Criteria: Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma). Patients without a large tumor burden. Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer. Poor renal function: Serum creatinine > 150 μmol/L, Known HIV infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with contra-indication to interferon, adriamycin, or rituximab. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator. Known sensitivity or allergy to murine products Adult patient under tutelage.

Sites / Locations

  • Groupe d'Etude des Lymphomes de l'adulte
  • Hôpital Henri Mondor
  • Hôpital Saint Louis
  • Service d'Hématologie - Centre Hospitalier Lyon-Sud
  • Centre Henri Becquerel

Outcomes

Primary Outcome Measures

Event free survival

Secondary Outcome Measures

Response rate
Overall survival

Full Information

First Posted
August 25, 2005
Last Updated
July 2, 2007
Sponsor
Lymphoma Study Association
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1. Study Identification

Unique Protocol Identification Number
NCT00136552
Brief Title
Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
Official Title
FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lymphoma Study Association

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.
Detailed Description
Follicular lymphoma patients with a large tumor burden will be randomized for 18 months of treatment with either: Arm A: CHVP + alpha2a-interferon. Patients will receive 12 courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days), one course every month for 6 months then one course every other month for 12 additional months associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months. Arm B: CHVP + alpha2a-interferon + rituximab. Patients will receive 6 monthly courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days) associated with 6 infusions of rituximab (375 mg/m2) associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
lymphoma, follicular, B-cell, rituximab, interferon

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rituximab
Primary Outcome Measure Information:
Title
Event free survival
Secondary Outcome Measure Information:
Title
Response rate
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months Patients previously untreated. Patients with at least one of the following symptoms requiring initiation of treatment: Bulky disease at study entry according to the Groupe d'Etudes Lymphomes Folliculare (GELF) criteria: nodal or extranodal mass > 7cm in its greater diameter B symptoms Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 1 Elevated serum lactate dehydrogenase (LDH) or beta2-microglobulin Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) Symptomatic splenic enlargement Compressive syndrome Pleural/peritoneal effusion Age must be > 18 years and less than 76 years Having previously signed a written informed consent form. Exclusion Criteria: Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma). Patients without a large tumor burden. Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer. Poor renal function: Serum creatinine > 150 μmol/L, Known HIV infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with contra-indication to interferon, adriamycin, or rituximab. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator. Known sensitivity or allergy to murine products Adult patient under tutelage.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles A Salles, MD PhD
Organizational Affiliation
Lymphoma Study Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe d'Etude des Lymphomes de l'adulte
City
Mont-Godinne
Country
Belgium
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
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 Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
8232429
Citation
Solal-Celigny P, Lepage E, Brousse N, Reyes F, Haioun C, Leporrier M, Peuchmaur M, Bosly A, Parlier Y, Brice P, et al. Recombinant interferon alfa-2b combined with a regimen containing doxorubicin in patients with advanced follicular lymphoma. Groupe d'Etude des Lymphomes de l'Adulte. N Engl J Med. 1993 Nov 25;329(22):1608-14. doi: 10.1056/NEJM199311253292203.
Results Reference
background
PubMed Identifier
9704735
Citation
McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
Results Reference
background
PubMed Identifier
18799723
Citation
Salles G, Mounier N, de Guibert S, Morschhauser F, Doyen C, Rossi JF, Haioun C, Brice P, Mahe B, Bouabdallah R, Audhuy B, Ferme C, Dartigeas C, Feugier P, Sebban C, Xerri L, Foussard C. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008 Dec 15;112(13):4824-31. doi: 10.1182/blood-2008-04-153189. Epub 2008 Sep 17.
Results Reference
derived
Links:
URL
http://www.gela.org
Description
Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)

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Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden

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