Clinical trial · Interventional
Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia
A Single-arm, Open-label, Pilot Study on the Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia
NCT05676710CI-TRIAL-00077563completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Large Granular T Lymphocytic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Linperlisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- PI3K inhibitors
- interventionNames
- Drug: Linperlisib
Primary outcomes (1)
- measure
- Overall response rate: HPR + HCR + CMR
- timeFrame
- 8 weeks
- description
- Percentage of patients with hematological response. 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.
Secondary outcomes (6)
- measure
- Incidence of the adverse event
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \<60ml/min * 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. * Previously treated with other PI3Kδ inhibitor. * Pregnant or breast-feeding patients * Patients considered to be ineligible for the study by the investigator for reasons other than the above
References
Publications (1)
- DERIVEDZhang L, Qiu C, Li R, Shen Y, Tian L, Chang H, Liang Q, Pan H, Gao Z, Li W, Zhao J, Fang L, Yu X, Xu J, Kuang Z, Yuan W, Chu Y, Shi J. KLRG1 re-defines a leukemic clone of CD8 effector T cells sensitive to PI3K inhibitor in T cell large granular lymphocytic leukemia. Cell Rep Med. 2025 Apr 15;6(4):102036. doi: 10.1016/j.xcrm.2025.102036. Epub 2025 Mar 26. PMID 40147444