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Clinical Trials in China / NCT06224257
Recruiting Phase 2

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

NCT06224257 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2023-12-03
Last updated
2025-08-05

Condition(s) studied

Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

Linperlisib

Linperlisib: Elevated PI3K activity in T-LGL likely plays an important role in the ability of the pathologic cells to avoid homeostatic apoptosis, since inhibition of this pathway leads to apoptosis in the population of cells harboring the pathologic clone. More importantly, the activity of this pathway may represent a kind of "Achilles heel" for T-LGL in that PI3K inhibitors alone are quite effective at inducing spontaneous apoptosis in the clonal CTLs after a short incubation.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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: 1. Hemoglobin \< 100g/L or RBC transfusion dependence 2. Neutrophil count \<0.5×10\^9/L or neutrophil count decreased with recurrent infection 3. Progressive splenomegaly and/or Massive Splenomegaly 4. Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc. 5. Severe B symptoms * Failure or intolerance to a first-line therapy * ECOG performance status ≤2 * Expected survival ≥ 6 months * Willing and able to comply with the requirements for this study and written informed consent 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 * History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc. * Received attenuated vaccine 4 in weeks before enrollment * Participation in another clinical trial within 4 weeks before the start of this trial * Have an allergy to Linperlisib or any other part of this medicine. * Pregnant or breast-feeding patients * Patients considered to be ineligible for the study by the investigator for reasons other than the above

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui Recruiting
Zhoukou Central Hospital Zhoukou Henan Recruiting
Regenerative Medicine Center Tianjin Tianjin Municipality Recruiting

More Institute of Hematology & Blood Diseases Hospital, China trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06224257 on ClinicalTrials.gov ↗ ← All trials in China