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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Enrolling

Phase 2

Conditions

Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Treatments

Drug: Linperlisib

Study type

Interventional

Funder types

Other

Identifiers

NCT06224257

IIT2023083

Details and patient eligibility

About

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.

Enrollment

41 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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