Status:
COMPLETED
Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
Lead Sponsor:
Lymphoma Study Association
Conditions:
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 c...
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 (cycloph...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00136552
Start Date
May 1 2000
End Date
December 1 2004
Last Update
July 3 2007
Active Locations (5)
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1
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
2
Hôpital Henri Mondor
Créteil, France, 94010
3
Hôpital Saint Louis
Paris, France, 75010
4
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495