Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517511
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients Smart Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients a Single-arm Multicenter Phase II Clinical Trial Smart Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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 is a prospective single-arm multi-center phase II clinical trial to evaluate the efficacy and safety of selinexor in combination with R-CHOP rituximab cyclophosphamide vincristine doxorubicin and prednisone followed by selinexor maintenance for untreated TP53-mutated diffuse large B-cell lymphoma DLBCL patients
Detailed Description:
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of selinexor in combination with R-CHOP for untreated TP53-mutated DLBCL patients
The induction phase consisted of 8 cycles of selinexor in combination with R-CHOP After 8 cycles of induction therapy if the response is assessed as complete remission CR maintenance therapy with selinexor will be conducted
The primary endpoint is complete response rate
The induction phase consisted of 8 cycles of selinexor in combination with R-CHOP After 8 cycles of induction therapy if the response is assessed as complete remission CR maintenance therapy with selinexor will be conducted
The primary endpoint is complete response rate
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