drugset / Trial / NCT07692529

A Clinical Study on the Efficacy and Safety of Zeprumetostat in Relapsed/Refractory Large Granular Lymphocyte Leukemia

NCT07692529

Phase 1 Not yet recruiting 10 enrolled Institute of Hematology & Blood Diseases Hospital, China
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-arm, prospective, exploratory clinical trial aimed at exploring the efficacy and safety of zeprumetostat in patients with relapsed/refractory large granular T-cell leukemia. The study is expected to enroll 10 patients with relapsed/refractory large granular T-cell leukemia for treatment with zeprumetostat . The patients will undergo a maximum 4-week screening period and then enter the treatment phase, where they will receive zeprumetostat 350mg twice daily orally. The treatment lasts for 28 consecutive days as one cycle. If adverse events occur during the treatment, they will be handled according to the suspension and resumption standards. The efficacy and safety will be evaluated after the patients complete two cycles of administration.

Timeline

Start
2026-08-30
Primary completion
2027-12-31
Completion
2028-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Zeprumetostat Small molecule 350 mg Oral

Indications

No indication recorded.