Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-04 @ 1:52 PM
Study NCT ID:
NCT06530550
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Organization:
Study Overview
Official Title:
Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: