A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma
M.D. Anderson Cancer Center
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
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 o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet all of the eligibility criteria to be enrolled on this study. 1. Subjects ≥18 years of age at the time the ICF is signed. 2. Have histologically confirmed FL, grades 1-3A 3. Must have been previously treated with at least 1 prior systemic therapy followed by relapsed, refractory or progressive disease. a. Systemic therapy includes: i. Anti-CD20 monoclonal antibody in combination with chemotherapy ii. Anti-CD20 monoclonal antibody monotherapy iii. Anti-CD20 monoclonal antibody in combination with lenalidomide iv. Anti-CD20 monoclonal antibody plus in…
Interventions
- DrugRituximab
Given by IV (vein)
- DrugLenalidomide
Given by PO
- DrugValemetostat
Given by PO
Location
- M D Anderson Cancer CenterHouston, Texas