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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall response rate
complete remission rate+ partial remission rate
Time frame: up to 5 years
The safety of PI3K inhibitors
Incidence of adverse events, serious adverse events and significant adverse event
Time frame: up to 5 years
Complete remession rate
Hematological PR was defined as an improvement in blood counts ANC \> 0.5 × 109/L; HGB increased by \>1 g/dL; PLT \> 50 × 109/L
Time frame: up to 5 years
Duration of remission
the time from response to progression/death (P/D)
Time frame: up to 5 years
Time to response
from the start of treatment to the first observed partial remission
Time frame: up to 5 years
Progression-free survival
the time from treatment initiation until disease progression or death
Time frame: up to 5 years
Overall survival
The time from the start of treatment to the patient's death from any cause
Time frame: up to 5 years
Disease control rate
the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).
Time frame: up to 5 years
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