Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05736965
Status:
RECRUITING
Last Update Posted:
2023-03-15
First Post:
2023-02-12
Brief Title:
A Study of Selinexor in Combination With Azacitidine and Venetoclax SAV Regimen in Treatment Naïve Participants With Acute Myeloid Leukemia
Sponsor:
Shanghai Tong Ren Hospital
Organization:
Shanghai Tong Ren Hospital
Study Overview
Official Title:
Clinical Efficacy and Safety of Selinexol Combined With Azacitidine and Venetoclax SAV Regimen in the Treatment of Acute Myeloid Leukemia AML-a Multi-center Single-arm Prospective Clinical Study
Status:
RECRUITING
Status Verified Date:
2023-03
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:
SAV
Brief Summary:
This is a prospective single-arm multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia
Detailed Description:
This is a prospective single-arm multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia
Selinexor will be given orally at 60mg d31017 Azacitidine will be given at 75mgm2 d1-3 8-9 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2 400mg on day 3-14
28 days per cycle patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects
Selinexor will be given orally at 60mg d31017 Azacitidine will be given at 75mgm2 d1-3 8-9 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2 400mg on day 3-14
28 days per cycle patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects
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