RecruitingPhase 2NCT06530550

PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

51 participants

Start Date

Aug 10, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphoma, T-Cell T-LGL Leukemia NK-LGL Leukemia

Summary

Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing PI3K inhibitor drugs (a type of targeted therapy) for patients with rare, slow-growing T-cell or NK-cell lymphomas (types of blood cancer) that have come back or are no longer responding to prior treatment. **You may be eligible if...** - You have been diagnosed with a relapsed or refractory indolent T/NK-cell lymphoma - You have received prior treatment that is no longer working - You are able to swallow oral medication **You may NOT be eligible if...** - You have previously taken a PI3K inhibitor drug - You have serious gastrointestinal problems (such as difficulty swallowing or malabsorption) that would prevent you from taking oral medication properly - You have other conditions that make this treatment unsafe 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

DRUGPI3K inhibitor

Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first