Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556199
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With RelapsedRefractory Primary Central Nervous System Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficiency and Safety of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With RelapsedRefractory Primary Central Nervous System Lymphoma A Prospective Single-arm Open Phase IbII Clinical Study
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:
This study is a prospective single-arm open label Phase IbII clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsedrefractory primary central nervous system lymphomaPCNSL Phase Ib used a 33 dose-climbing design to confirm the safety maximum-tolerated dose MTDif any and recommended phaseII dose RP2D of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles Phase II was a comprehensive evaluation of efficacy and safety Subjects who achieved complete remission or partial remission were treated with anti-PD-1 monoclonal antibody maintenance therapy until disease progression or recurrence intolerance of toxicity death loss of follow-up withdrawal of notification whatever happened first
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