Clinical trial · Interventional
Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden
NCT00136552CI-TRIAL-00000783completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event free survival
Secondary outcomes (2)
- measure
- Response rate
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDSolal-Celigny P, Lepage E, Brousse N, Reyes F, Haioun C, Leporrier M, Peuchmaur M, Bosly A, Parlier Y, Brice P, et al. Recombinant interferon alfa-2b combined with a regimen containing doxorubicin in patients with advanced follicular lymphoma. Groupe d'Etude des Lymphomes de l'Adulte. N Engl J Med. 1993 Nov 25;329(22):1608-14. doi: 10.1056/NEJM199311253292203. PMID 8232429
- BACKGROUNDMcLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825. PMID 9704735
- DERIVEDSalles G, Mounier N, de Guibert S, Morschhauser F, Doyen C, Rossi JF, Haioun C, Brice P, Mahe B, Bouabdallah R, Audhuy B, Ferme C, Dartigeas C, Feugier P, Sebban C, Xerri L, Foussard C. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008 Dec 15;112(13):4824-31. doi: 10.1182/blood-2008-04-153189. Epub 2008 Sep 17. PMID 18799723