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

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

NCT ID: NCT06224257

Condition: Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, T-Cell

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Linperlisib
Description: 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.
Arm group label: Linperlisib

Other name: PI3K Inhibitor

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.

Criteria for 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： 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Anhui Provincial Hospital

Address:
City: Hefei
Country: China

Status: Recruiting

Contact:
Last name: Xiaoyu Zhu
Email: xiaoyuz@ustc.edu.cn

Facility:
Name: Zhoukou Central Hospital

Address:
City: Zhoukou
Country: China

Status: Recruiting

Contact:
Last name: Qian Liang, PhD

Phone: 15703815972
Email: lqw141230@163.com

Facility:
Name: Regenerative Medicine Center

Address:
City: Tianjin
Country: China

Status: Recruiting

Contact:
Last name: Lele Zhang

Phone: 15811139278
Email: zhanglele@ihcams.ac.cn

Start date: December 3, 2023

Completion date: October 31, 2025

Lead sponsor:
Agency: Institute of Hematology & Blood Diseases Hospital, China
Agency class: Other

Collaborator:
Agency: YL-Pharma
Agency class: Other

Source: Institute of Hematology & Blood Diseases Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06224257