CompletedPhase 1

Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

China8 participantsStarted 2023-02-10

Plain-language summary

This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Severe B symptoms

What they're measuring

Overall response rate: HPR + HCR + CMR

Timeframe: 8 weeks

Trial details

NCT IDNCT05676710

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Relapsed/Refractory Large Granular T Lymphocytic Leukemia trials