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.
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.
None
Single group
zeprumetostat
DrugThe 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 proportion of achieving hematological remission after two cycles of treatment
Hematological response is evaluated by hemoglobin (Hb), absolute neutrophil count (ANC), platelet count (PLT), absolute lymphocyte count (ALC), absolute large granular lymphocyte count, and blood transfusion.
The incidence of adverse reactions during treatment
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event
The time to achieve partial hematological remission
HPR is assessed by Hb, ANC, PLT, ALC, absolute large granular lymphocyte count and blood transfusion
Time to achieve complete hematologic response
HCR is assessed by Hb, ANC, PLT, ALC, and absolute large granular lymphocyte count.
Time to achieve complete molecular response
CMR is assessed by Hb, ANC, PLT, ALC, and absolute large granular lymphocyte count
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This trial is not recruiting at the moment. You can still explore other options:
