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

Lymphoma Clinical Trial

Official title:

FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136552
• Other study ID #: FL2000
• Secondary ID: PHRC
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: July 2, 2007
• Start date: May 2000
• Est. completion date: December 2004

Study information

• Verified date: July 2007
• Source: Lymphoma Study Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• rituximab

Locations

Country	Name	City	State
Belgium	Groupe d'Etude des Lymphomes de l'adulte	Mont-Godinne
France	Hôpital Henri Mondor	Créteil
France	Hôpital Saint Louis	Paris
France	Service d'Hématologie - Centre Hospitalier Lyon-Sud	Pierre-Bénite cedex
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Study Association

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (2)

McLaughlin P, Grillo-López 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. — View Citation

Solal-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival
Secondary	Response rate
Secondary	Overall survival

External Links

•   Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)