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A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia — SAV  

AML, Adult Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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, d3,10,17 Azacitidine will be given at 75mg/m2, 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05736965
Study type Interventional
Source Shanghai Tong Ren Hospital
Contact Ligen Liu, MD
Phone 18017337037
Email llg3532@shtrhospital.com
Status Recruiting
Phase Phase 2
Start date February 20, 2023
Completion date April 30, 2027
View Details
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