NCT05736965

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Shanghai Tong Ren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• AML, Adult

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor 60mg, PO d3,10,17
DRUG	Azacitidine	Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
DRUG	Venetoclax	Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-03-30
• Completion: 2027-04-30
• First posted: 2023-02-21
• Last updated: 2023-03-15

Locations

19 sites across 1 country: China