A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Tazemetostat for the Treatment of Patients With Relapsed/Refractory Follicular Lymphoma

2021-TAZ-00CH1

Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat

2022-07-29

2023-06-01

2024-02-01

Recruiting

Early phase I

39

Inclusion Criteria: 1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure; 2. Age ≥18 years; 3. Patients with histologically confirmed R/R FL (Grades 1, 2, 3a) 4. Patients must have one measurable lesion 5. Life expectancy ≥ 12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 7. Adequate bone marrow function, renal function and hepatic function: 8. Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or cytomegalovirus (CMV) is inactive: 9. Female patients of childbearing potential must agree to adopt dual contraceptive method Exclusion Criteria: 1. Previous use of Tazemetostat or other EZH2 inhibitors; 2. Patients with invasion of lymphoma to the central nervous system (CNS) or the pia mater; 3. Previous bone marrow malignancies, 4. Abnormalities associated with MDS and myeloproliferative neoplasms observed by cytogenetic testing and DNA sequencing;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will be enrolled to Cohort 1 and 2 based on the EZH2 mutations, respectively:\n\n* Cohort 1: MT patients with R/R FL; planned enrollment number: 19;\n* Cohort 2: WT patients with R/R FL; planned enrollment number: 20; Both cohorts have same dose administered: 800 mg, twice per day (BID), continuously, at a suggested interval of 12 hours between two doses.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 39, 'type': 'ESTIMATED'}}

2022-09-30