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

Lymphoma Study Association (LYSA)

Status and phase

Completed

Phase 3

Conditions

Lymphoma

Treatments

Drug: rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00136552

PHRC

FL2000

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.