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

July 2, 2007 updated by: Lymphoma Study Association

FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Mont-Godinne, Belgium
        • Groupe d'Etude des Lymphomes de l'Adulte
  • France
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pierre-Bénite cedex, France, 69495
        • Service d'Hématologie - Centre Hospitalier Lyon-Sud
      • Rouen, France, 76038
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Event free survival

Secondary Outcome Measures

Outcome Measure
Response rate
Overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Investigators

  • Principal Investigator: Gilles A Salles, MD PhD, Lymphoma Study Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 3, 2007

Last Update Submitted That Met QC Criteria

July 2, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FL2000
  • PHRC (2001/1939)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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