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

This study has been completed.
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00136552
First received: August 25, 2005
Last updated: July 2, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Event free survival

Secondary Outcome Measures:
  • Response rate
  • Overall survival

Estimated Enrollment: 360
Study Start Date: May 2000
Estimated Study Completion Date: December 2004
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136552

Locations
Belgium
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
France
Hôpital Henri Mondor
Créteil, France, 94010
Hôpital Saint Louis
Paris, France, 75010
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495
Centre Henri Becquerel
Rouen, France, 76038
Sponsors and Collaborators
Lymphoma Study Association
Investigators
Principal Investigator: Gilles A Salles, MD PhD Lymphoma Study Association
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00136552     History of Changes
Other Study ID Numbers: FL2000, PHRC
Study First Received: August 25, 2005
Last Updated: July 2, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
lymphoma
follicular
B-cell
rituximab
interferon

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014