Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma
NCT ID: NCT05467943
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2022-07-29
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
* 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.
TREATMENT
NONE
Study Groups
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Cohort 1 based on the EZH2 mutations
MT patients with R/R FL; planned enrollment number: 19;
Tazemetostat
All patients will receive 800 mg of Tazemetostat, BID, administered in continuous 28-day therapeutic cycle
Cohort 2 based on the EZH2 mutations,
WT patients with R/R FL; planned enrollment number: 20;
Tazemetostat
All patients will receive 800 mg of Tazemetostat, BID, administered in continuous 28-day therapeutic cycle
Interventions
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Tazemetostat
All patients will receive 800 mg of Tazemetostat, BID, administered in continuous 28-day therapeutic cycle
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
ALL
No
Sponsors
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Hutchmed
INDUSTRY
Responsible Party
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Principal Investigators
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Junning Cao, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Cancer Center
Locations
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Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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2021-TAZ-00CH1
Identifier Type: -
Identifier Source: org_study_id
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