Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442022
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2020-06-10
Brief Title:
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum R-GDP with or Without Selinexor in Patients with RelapsedRefractory Diffuse Large B-cell Lymphoma
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
Official Title:
A Phase 23 Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum R-GDP with or Without Selinexor in Patients with RelapsedRefractory Diffuse Large B-cell Lymphoma RR DLBCL
Status:
RECRUITING
Status Verified Date:
2024-09
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 purpose of this Phase 23 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP SR-GDP in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation HSCT or chimeric antigen receptor T cell CAR-T therapy This study consists of 3 arms each in Phase 2 and 3 Phase 2 portion of the study will assess the two doses of selinexor 40 milligram mg or 60 mg in combination with R-GDP for up to 6 cycles 21-day per cycle followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response Phase 3 portion of the study will evaluate the selected dose of SR-GDP identified in Phase 2 versus standard R-GDP matching placebo for up to 6 cycles 21-day per cycle followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000605-84 | EUDRACT_NUMBER | None | None |