NCT00136552

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3 lymphoma

Timeline
Completed

Started May 2000

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
Last Updated

July 3, 2007

Status Verified

July 1, 2007

First QC Date

August 25, 2005

Last Update Submit

July 2, 2007

Conditions

Lymphoma

Keywords

lymphomafollicularB-cellrituximabinterferon

Outcome Measures

Primary Outcomes (1)

  • Event free survival

Secondary Outcomes (2)

  • Response rate

  • Overall survival

Interventions

rituximabDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Groupe d'Etude des Lymphomes de l'adulte

Mont-Godinne, Belgium

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Service d'Hématologie - Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Related Publications (3)

  • 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.

    PMID: 8232429BACKGROUND

  • 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.

    PMID: 9704735BACKGROUND

  • 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.

    PMID: 18799723DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gilles A Salles, MD PhD

    Lymphoma Study Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

May 1, 2000

Study Completion

December 1, 2004

Last Updated

July 3, 2007

Record last verified: 2007-07

Locations

FR(4)BE(1)