OncoMatch/Clinical Trials/NCT04224493
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.
Is NCT04224493 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Tazemetostat and Tazemetostat for relapsed/refractory follicular lymphoma.
Treatment: Tazemetostat · Tazemetostat · Lenalidomide · Rituximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: EZH2 any tested
Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy (rituximab, chemotherapy, radioimmunoconjugates, autologous/allogeneic hematopoietic stem cell transplant, CAR T cell therapy)
Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy
Cannot have received: EZH2 inhibitor (tazemetostat)
Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
Cannot have received: immunomodulatory drug (IMiD) (lenalidomide)
Prior exposure to lenalidomide or drugs of the same class.
Lab requirements
Blood counts
ANC ≥1000/mm3 (≥1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10^9/L) with bone marrow infiltration (without growth factor support for at least 14 days); Platelets ≥75,000/mm3 (≥75 × 10^9/L) (evaluated at least 7 days after last platelet transfusion); Hemoglobin ≥9.0 g/dL (may receive transfusion)
Kidney function
Calculated creatinine clearance ≥30 mL/minute per Cockcroft and Gault formula
Liver function
Total bilirubin ≤1.5 × ULN except for unconjugated hyperbilirubinemia of Gilbert's syndrome; ALP (in the absence of bone disease), ALT, and AST ≤3 × ULN (≤5 × ULN if subject has liver infiltration)
Cardiac function
No significant cardiovascular impairment: history of congestive heart failure greater than NYHA Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia. QTcF <480 msec at screening, no history of long QT syndrome.
Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula. Adequate bone marrow function: ANC ≥1000/mm3... Platelets ≥75,000/mm3... Hemoglobin ≥9.0 g/dL... Adequate liver function: Total bilirubin ≤1.5 × ULN... ALP, ALT, and AST ≤3 × ULN (≤5 × ULN if subject has liver infiltration). Significant cardiovascular impairment: history of congestive heart failure greater than NYHA Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Southern Cancer Center · Mobile, Alabama
- Arizona Oncology Associates - Tuscon-Rusadill Road · Tucson, Arizona
- TOI - Clinical Research · Cerritos, California
- UCSF Fresno · Clovis, California
- UC San Diego Health Sciences · La Jolla, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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