Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
This study has been completed.
Sponsor:
Lymphoma Study Association
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00136552
First received: August 25, 2005
Last updated: July 2, 2007
Last verified: July 2007
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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 |
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
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 May 21, 2013