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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations