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Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas:An Open, Prospective, Exploratory Clinical Trial
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.
Plan to enroll 51 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive PI3K inhibitor treatment (including 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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Start Date
August 10, 2024
Primary Completion Date
August 10, 2026
Completion Date
July 10, 2028
Last Updated
August 12, 2025
51
ESTIMATED participants
PI3K inhibitor
DRUG
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT06561048
NCT07356245
Data Source & Attribution
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