Evaluating Linperlisib for treating relapsed large granular T lymphocytic leukemia
A Phase 2, Multicenter, Single-arm, Open-label Study on the Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia
This study is testing a new drug called Linperlisib to see if it can help adults with relapsed large granular T lymphocytic leukemia feel better and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Hefei, Anhui and 2 other locations) |
| Trial ID | NCT06224257 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial is a multicenter, single-arm study designed to assess the efficacy and safety of Linperlisib, a PI3K delta inhibitor, in patients with relapsed or refractory large granular T lymphocytic leukemia. Participants must be adults aged 18 or older with a confirmed diagnosis of T-LGLL and specific treatment indications. The study will monitor the treatment's effectiveness and safety profile in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults with relapsed or refractory T-LGLL who have failed or are intolerant to first-line therapy.
Not a fit: Patients with a history of other lymphoproliferative neoplasms or recent malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory large granular T lymphocytic leukemia.
How similar studies have performed: While this approach is novel for this specific condition, similar studies with PI3K inhibitors have shown promise in other hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hefei, Anhui and 2 other locations
- Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
- Zhoukou Central Hospital — Zhoukou, Henan, China (Recruiting)
- Regenerative Medicine Center — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jun Shi, PhD — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Jun Shi, PhD
- Email: shijun@ihcams.ac.cn
- Phone: 13752253515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.