About this trial
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.
Eligibility criteria
Qualifiers
Hemoglobin < 100g/L or RBC transfusion dependence
Neutrophil count <0.5×10^9/L or neutrophil count decreased with recurrent infection
Progressive splenomegaly and/or Massive Splenomegaly
Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc.
Disqualifiers
None
Trial design
Treatments tested in this trial
- zeprumetostat