Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma

HUTCHMED

Status and phase: Active, not recruiting; Phase 2

Conditions: Relapsed/Refractory Follicular Lymphoma With EZH2

Treatments: Drug: Tazemetostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05467943

2021-TAZ-00CH1

Details and patient eligibility

About

Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Cohort 1 based on the EZH2 mutations

Experimental group

Description:

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

Treatment:

Drug: Tazemetostat

Cohort 2 based on the EZH2 mutations,

Experimental group

Description:

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

Treatment:

Drug: Tazemetostat