RecruitingPhase 2NCT06224257

Efficacy and Safety of Linperlisib in Relapsed/Refractory 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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

41 participants

Start Date

Dec 3, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called linperlisib can treat a rare type of blood cancer called T-cell large granular lymphocytic leukemia (T-LGLL), which often causes low blood counts including severe anemia or low neutrophils, and typically affects middle-aged to older adults. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL) - You have symptoms that require treatment, such as low hemoglobin, dangerously low neutrophils, enlarged spleen, or autoimmune disease linked to your leukemia - Your T-LGLL has failed or you could not tolerate a first standard treatment - Your liver, kidney function, and overall health are adequate **You may NOT be eligible if...** - You have another blood cancer or lymphoma - You have had a prior organ or stem cell transplant - You have active infections requiring treatment, or active hepatitis B, C, or HIV - You are pregnant or breastfeeding - You have a history of severe lung problems like pulmonary fibrosis - You have had another cancer within the last 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinperlisib

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.


Locations(3)

Anhui Provincial Hospital

Hefei, Anhui, China

Zhoukou Central Hospital

Zhoukou, Henan, China

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06224257