Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583083
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural KillerT Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Phase 2 Randomized Trial of Sintilimab PD-1 Antibody With P-GEMOX Versus the P-GEMOX Regimen in the Teatment of Newly Diagnosed Advanced-stage Extranodal Natural KillerT Cell Lymphoma ENKTL SPIRIT-02
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SPIRIT-02
Brief Summary:
Extranodal NKT-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma While the overall survival rates have improved for early-stage ENKTL patients the prognosis for those with advanced disease remains poor and there is currently no standard treatment PD-1PD-L1 inhibitors have demonstrated significant efficacy in various cancers and recent studies have shown promising results in extranodal NKT-cell lymphoma as well Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients their effectiveness when combined with chemotherapy as a first-line treatment remains unclear This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NKT-cell lymphoma patients while also exploring potential biomarkers that may predict treatment outcomes offering new therapeutic options for extranodal NKT-cell lymphoma patients
Detailed Description:
None
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