Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma
Trial Parameters
Brief Summary
To learn if obinutuzumab in combination with CC-99282 can help to control previously untreated, high tumor burden FL
Eligibility Criteria
Inclusion Criteria: Patients must meet the following criteria for study entry: * Histologically diagnosed follicular lymphoma grade 1-3a * Have no prior systemic treatment for lymphoma * Stage II, III or IV disease * Age ≥18 years * Performance status ≤2 on the ECOG scale * High-tumor burden disease based on GELF criteria36 * A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter * At least 3 nodal or extranodal sites ≥ 3 cm in diameter * Presence of at least one B symptom * Fever (\>38 ℃), night sweats, weight loss \> 10% in the past 6 months * Symptomatic splenomegaly (or size \>13cm) * Impending organ compression or involvement (ureteral, orbital, gastrointestinal) * Any of the following cytopenias due to bone marrow involvement of lymphoma * Hemoglobin ≤ 10 g/dL * Platelets ≤ 100 x 109/L * Absolute neutrophil count (ANC) \< 1.5x109/L * Pleural effusion or ascites * Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal le