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

NCT06224257 | Recruiting Phase 2

• 1 other identifier: IIT2023083
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

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.

Conditions

Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with hematologic remission

  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.

  8-12 weeks

Secondary Outcomes (1)

• Incidence of the adverse event

  8-12 weeks

Study Arms (1)

Linperlisib

EXPERIMENTAL

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

Drug: Linperlisib

Interventions

Linperlisib DRUG

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.

Also known as: PI3K Inhibitor

Linperlisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• YL-Pharma: collaborator

Study Sites (3)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, China

RECRUITING

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Shi, PhD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Shi, PhD

CONTACT

13752253515; shijun@ihcams.ac.cn

Lele Zhang, PhD

CONTACT

15811139278; zhanglele@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 25, 2024
• Study Start: December 3, 2023
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)