PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Subjects who have previously used any PI3K inhibitors;
Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
Trial design
Design model
Single group
Treatments tested in this trial
PI3K inhibitor
DrugLinperlisib 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
Treatment groups
51 Participants
are divided into 1 treatment groupGroup A: PI3K inhibitorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate
complete remission rate+ partial remission rate
Time frame
up to 5 yearsSecondary outcomes
1
The safety of PI3K inhibitors
Incidence of adverse events, serious adverse events and significant adverse event
Time frame
up to 5 years2
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 years3
Duration of remission
the time from response to progression/death (P/D)
Time frame
up to 5 years4
Time to response
from the start of treatment to the first observed partial remission
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov