NCT05683171

A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find a recommended dose of valemetostat that can be given in combination with rituximab and lenalidomide to patients with follicular lymphoma. The safety and effects of this drug combination will also be studied

Detailed description

Primary Objectives: Phase 1 --Evaluate the safety and tolerability of valemetostat in combination with R2 in subjects with R/R FL and determine the recommended phase 2 dose (RP2D) for evaluation in phase 2. Secondary Objectives: Phase 1 * Evaluate the efficacy of valemetostat in combination with R2 in R/R FL * Evaluate the pharmacokinetics (PK) of valemetostat in combination with R2 Exploratory Objective: Phase 1 * Evaluate pharmacodynamic profile of valemetostat * Evaluate the efficacy of valemetostat in combination with R2 in R/R FL Primary Objective: Phase 2 --Evaluate the efficacy of valemetostat in combination with R2 in R/R FL Secondary Objective: Phase 2 * Evaluate the ORR * Evaluate the DOR * Evaluate the time to next anti-lymphoma treatment (TTNT) * Evaluate the safety and tolerability * Evaluate the PK of valemetostat in combination with R2 Exploratory Objective: Phase 2 * Evaluate the PFS of valemetostat in combination with R2 in R/R FL * Evaluate OS * Evaluate the effect of valemetostat in combination with R2 in R/R FL on epigenetic remodeling and gene expression * Evaluate changes in tumor/immune microenvironment * Evaluate pharmacodynamic profile of valemetostat

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Given by IV (vein)
DRUG	Lenalidomide	Given by PO
DRUG	Valemetostat	Given by PO

Timeline

• Start date: 2023-05-19
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-01-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study