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)
Proportion of patients with hematologic remission — 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.
Trial sites (3)
Facility
City
Region
Status
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
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.
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