Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
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ClinicalTrials.gov Identifier: NCT00136552 |
Recruitment Status :
Completed
First Posted : August 29, 2005
Last Update Posted : July 3, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: rituximab | Phase 3 |
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 (Clinical Trial) |
Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden |
Study Start Date : | May 2000 |
Study Completion Date : | December 2004 |

- Event free survival
- Response rate
- Overall survival

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months
- Patients previously untreated.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136552
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 |
Principal Investigator: | Gilles A Salles, MD PhD | Lymphoma Study Association |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00136552 |
Other Study ID Numbers: |
FL2000 PHRC |
First Posted: | August 29, 2005 Key Record Dates |
Last Update Posted: | July 3, 2007 |
Last Verified: | July 2007 |
lymphoma follicular B-cell rituximab interferon |
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |