Cancer Type: Malignant Hematology
Study Type: Treatment
Phase: Phase I
Principal Investigator: Gaballa, Sameh
A Phase 1b/3 Double-Blind, Randomized,Active-Controlled, 3-Stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination with Lenalidomide Plus Rituximab in Subjects with Relapsed/Refractory Follicular Lymphoma
This is a multicenter, double-blind, active-controlled, randomized, 3-stage, biomarker enrichment design featuring early futility stopping and sample-size re-estimation with safety run-in designed to evaluate the efficacy and safety of tazemetostat in combination with lenalidomide and rituximab (R2) in patients with relapsed or refractory (R/R) follicular lymphoma (FL), who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
Primary Objective: Evaluate the safety and tolerability of tazemetostat in combination with lenalidomide + rituximab (R2) in subjects with relapsed/refractory (R/R) follicular lymphoma (FL) and to select a recommended phase 3 dose (RP3D) of tazemetostat for further evaluation in phase 3. Secondary Objective: Assess the clinical activity and pharmacokinetics of tazemetostat when administered concomitantly with R2 in subjects with R/R FL. Stage 2 and Optional Stage 3 (Based on Stage 2 Futility Analysis) Primary Objective: Evaluate and compare progression-free survival (PFS), as assessed by Investigators, of tazemetostat + R2 versus placebo + R2 in subjects with R/R FL who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy. Secondary Objectives: Evaluate and compare PFS by blinded independent review committee (IRC) Evaluate and compare objective response rate (ORR) Evaluate and compare the duration of response (DOR) Evaluate and compare the duration of complete response (DOCR) Evaluate and compare the disease control rate (DCR) Evaluate and compare health-related quality of life as measured by the EuroQOL 5-Dimension 5-Level (EQ-5D-5L) instrument and the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Evaluate and compare the overall survival (OS) Assess population pharmacokinetic (PK) parameters, including exposure-response of tazemetostat when administered in combination with R2 Evaluate and compare safety and tolerability.
CC-5013 (Lenalidomide); EPZ-6438 (Tazemetostat); Lenalidomide (Revlimid); Rituxan (rituximab); Tazemetostat (); Tazemetostat/Placebo (); rituximab ()
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