A Phase 2, Multicenter, Single-arm, Open-label Study on the Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Institute of Hematology & Blood Diseases Hospital, China3 sites in 1 country41 target enrollmentDecember 3, 2023

ConditionsRelapsed/Refractory Large Granular T Lymphocytic Leukemia

InterventionsLinperlisib

DrugsLinperlisib

Overview

Phase: Phase 2
Intervention: Linperlisib
Conditions: Relapsed/Refractory Large Granular T Lymphocytic Leukemia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Enrollment: 41
Locations: 3
Primary Endpoint: Proportion of patients with hematologic remission
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multicenter, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.

Registry

clinicaltrials.gov

Start Date

December 3, 2023

End Date

January 31, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female age ≥ 18 years
•Diagnosis of T-cell large granular lymphocytic leukemia (T-LGLL)
•Meet any of the following indications for treatment：
•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
•Failure or intolerance to a first-line therapy
•ECOG performance status ≤2

Exclusion Criteria

•History of other lymphoproliferative neoplasms
•Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
•Previously received organ or stem cell transplantation
•Patients with active infection within 2 weeks before giving the first dose of medication
•Patients with HBV, HCV, HIV or other infections that require treatment
•History of immunodeficiency, or congenital immunodeficiency disorders
•Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
•Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
•Renal impairment: creatinine clearance \<30ml/min
•History of mental illness

Arms & Interventions

Linperlisib

Linperlisib was administered at 80 mg every day, orally in a 28-day cycle until disease progression or intolerable toxicity occurred.

Intervention: Linperlisib

Outcomes

Primary Outcomes

Proportion of patients with hematologic remission

Time Frame: 8-12 weeks

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.