Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring lymphoma, follicular, B-cell, rituximab, interferon
Eligibility 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.
Sites / Locations
- Groupe d'Etude des Lymphomes de l'adulte
- Hôpital Henri Mondor
- Hôpital Saint Louis
- Service d'Hématologie - Centre Hospitalier Lyon-Sud
- Centre Henri Becquerel