Actively Recruiting
Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-05
41
Participants Needed
3
Research Sites
112 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
Y
YL-Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age �3E= 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�D710^9/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 �3C=2
- Expected survival �3E= 6 months
- Willing and able to comply with the requirements for this study and written informed consent
You will not qualify if you...
- 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 �3E=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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
2
Zhoukou Central Hospital
Zhoukou, Henan, China
Actively Recruiting
3
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jun Shi, PhD
CONTACT
L
Lele Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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