Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerance of golcadomide in mantle cell lymphoma (MCL) patients who were resistant or intolerant to covalent bruton's tyrosine kinase inhibitors (cBTKi). II. To evaluate the safety and tolerance of golcadomide in combination with rituximab in MCL patients who were resistant or intolerant to cBTKi. III. To estimate the efficacy of golcadomide and rituximab in MCL patients who were resistant or intolerant to cBTKi. SECONDARY OBJECTIVES: I. To evaluate the complete response rate (CR) of the combination of golcadomide and rituximab. II. To evaluate the durability of response by the duration of response (DOR) and duration of complete response (DOCR). EXPLORATORY OBJECTIVES: I. Correlate clinical response with changes in baseline T cell characteristics and cytokine profiles. II. To measure the rate of minimal residual disease undetectability in responding patients. OUTLINE: This is a phase I, dose-escalation study of golcadomide followed by a phase II study. Patients are assigned to 1 of 2 phases. PHASE I: Patients receive golcadomide orally (PO) once daily (QD) on days 1-14 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and positron emission tomography (PET)/computed tomography (CT) throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study. PHASE II: Patients receive golcadomide PO QD on days 1-14 of each cycle. Patients also receive rituximab intravenously (IV) on days 1, 8, 15 and 22 of cycle 1 and then day 1 of even cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study. After completion of study treatment, patients are followed up at 30 days, and then up to 3 years.