Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530550
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
PI3K Inhibitors for the Treatment of RelapsedRefractory Indolent TNK-cell Lymphomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Clinical Study of PI3K Inhibitors in the Treatment of RelapsedRefractory Indolent TNK-Cell LymphomasAn 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Indolent TNK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from TNK cells characterized by slow growth and proliferation but currently remain incurable For indolent TNK-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 relapsedrefractory indolent TNK-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 relapsedrefractory indolent TNK-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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None