Clinical trial NCT05467943: Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed/Refractory Follicular Lymphoma With EZH2
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All patients will be enrolled to Cohort 1 and 2 based on the EZH2 mutations, respectively:

* Cohort 1: MT patients with R/R FL; planned enrollment number: 19;
* 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.
Primary purpose: TREATMENT

Brief summary: Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat

Detailed description: This is an open-label, monotherapy, Phase II Study clinical study. The objective is to evaluate the efficacy, safety, and pharmacokinetics of Tazemetostat in the treatment of patients with relapsed/refractory follicular lymphoma. It is planned to enroll 39 Chinese patients in 2 cohorts.

Eligibility criteria: 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;

Primary outcomes:
measure: efficacy of Tazemetostat in EZH2 (MT) (Cohort 1)
timeFrame: 22 months
Secondary outcomes:
measure: efficacy of Tazemetostat in EZH2 (WT) (Cohort 2)
timeFrame: 22 months
measure: safety of Tazemetostat in EZH2 (WT) (Cohort 2)
timeFrame: 22 months
measure: Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood
timeFrame: Cycle1Day1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration ; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle2Day1 and Cycle3Day1: predose of first administration.
measure: Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood
timeFrame: Cycle1Day 1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle2Day1 and Cycle3Day1: predose of first administration.
measure: Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat
timeFrame: Cycle1Day1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose
measure: Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood
timeFrame: Cycle1Day15, Cycle2Day1 and Cycle3Day1: predose of first administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Shanghai Cancer Center
name: Junning Cao, MD
role: PRINCIPAL_INVESTIGATOR
References: