Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma

NCT05467943 | Completed Phase 2

• 1 other identifier: 2021-TAZ-00CH1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat

Conditions

Relapsed/Refractory Follicular Lymphoma With EZH2

Outcome Measures

Primary Outcomes (1)

• efficacy of Tazemetostat in EZH2 (MT) (Cohort 1)

  Objective response rate (ORR) of Cohort 1 evaluated by the Independent Review Committee (IRC) \[based on the International Working Group-Non-Hodgkin's Lymphoma \[IWG-NHL\] (Cheson) 2007\]

  22 months

Secondary Outcomes (6)

• efficacy of Tazemetostat in EZH2 (WT) (Cohort 2)

  22 months

• safety of Tazemetostat in EZH2 (WT) (Cohort 2)

  22 months

• Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood

  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.

• Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood

  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.

• Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat

  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

Study Arms (2)

Cohort 1 based on the EZH2 mutations

EXPERIMENTAL

MT patients with R/R FL; planned enrollment number: 19;

Drug: Tazemetostat

Cohort 2 based on the EZH2 mutations,

EXPERIMENTAL

WT patients with R/R FL; planned enrollment number: 20;

Drug: Tazemetostat

Interventions

Tazemetostat DRUG

All patients will receive 800 mg of Tazemetostat, BID, administered in continuous 28-day therapeutic cycle

Cohort 1 based on the EZH2 mutations; Cohort 2 based on the EZH2 mutations,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
• Age ≥18 years;
• Patients with histologically confirmed R/R FL (Grades 1, 2, 3a)
• Patients must have one measurable lesion
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
• Adequate bone marrow function, renal function and hepatic function:
• Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or cytomegalovirus (CMV) is inactive:
• Female patients of childbearing potential must agree to adopt dual contraceptive method

You may not qualify if:

• Previous use of Tazemetostat or other EZH2 inhibitors;
• Patients with invasion of lymphoma to the central nervous system (CNS) or the pia mater;
• Previous bone marrow malignancies,
• Abnormalities associated with MDS and myeloproliferative neoplasms observed by cytogenetic testing and DNA sequencing;

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Cao J, Chen G, Qiu L, Zhang L, Jiang M, Cheng Y, Zhang Q, Liu L, Li P, Shuang Y, Wang H, Xue H, Wu H, Zheng M, Zhou K, Li Z, Jing H, Yang W, Zhu Z, Li W, Wangwu J, Huang H, Jia Q, Chen D, Fan S, Shi MM, Su W. Efficacy and safety of tazemetostat, an EZH2 inhibitor, in Chinese patients with relapsed/refractory follicular lymphoma: a multicentre, single-arm, phase 2 study. EClinicalMedicine. 2025 Aug 18;87:103399. doi: 10.1016/j.eclinm.2025.103399. eCollection 2025 Sep.

  PMID: 40896460 DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

tazemetostat

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junning Cao, MD

  Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 21, 2022
• Study Start: July 29, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)