A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in… (NCT04224493) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.
United States555 participantsStarted 2020-06-11
Plain-language summary
The participants of this study would have relapsed/refractory follicular lymphoma.
Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works.
Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed.
Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
✓. Males or females are ≥18 years of age, or per country adult legal age regulations, at the time of providing voluntary written informed consent.
✓. Life expectancy ≥3 months before enrollment.
✓. Meet requirement for hepatitis and human immunodeficiency virus (HIV) infection as follows
Exclusion criteria
✕. Have histologically confirmed FL, Grades 1 to 3A.
✕. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:
✕. Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression \<6 months after last dose).
✕. Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).
What they're measuring
1
Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)
Timeframe: Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1
2
Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) population
Timeframe: Stage 2: Up to 72 months
3
PFS in the Intent-to-treat mutant-type (ITT-MT) population
. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
✕0. Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy must have either resolved to Grade 1 per NCI CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.
✕1. Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification
✕2. Time between prior anticancer therapy and first dose of tazemetostat as follows: