Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376721
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-15
Brief Title:
Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or RelapsedRefractory NKT-cell Lymphoma
Sponsor:
Beijing Tongren Hospital
Organization:
Beijing Tongren Hospital
Study Overview
Official Title:
A Phase IbII Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or RelapsedRefractory NKT-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The patients diagnosed with relapsedrefractory or advanced NKT-cell Lymphoma rr NKTCL were selected as the research objects To explore effective and safe treatment for advanced or rr NKTCL the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment
Detailed Description:
This is a prospective single-arm single-center IbII clinical trial that included an initial safety run-in phase with safety monitoring before the main enrollment expansion phaseThe aim of phase Ib is to evaluate the recommended phase 2 dose and dose-limiting toxicity DLT and the aim of phase II study is to evaluate for the first time the safety and efficacy of the treatment of Linperlisib combined with PD-1 blockade Camrelizumab and Pegaspargase in patients diagnosed with advanced or rr ENKTL respectively
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None