NCT05726110

Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia

A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanxi Bethune Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia

Detailed description

Main Purpose： To observe the efficacy of selinexor in combination with HAD or CAG regimen for relapsed and refractory acute myeloid leukemia :complete remission rate (CR rate), partial remission rate (PR rate), no remission rate (NR rate), complete remission with incomplete hematologic recovery(CRi rate) Secondary Purposes： 1. To observe the recurrence rate of selinexor combined with HAD or CAG regimen for relapsed and refractory acute myeloid leukemia, treatment-related mortality(TRM), Overall Survival (OS), Event-Free Survival (EFS); 2. Safety indicators: to observe adverse events and deaths during treatment with selinexor in combination with HAD or CAG regimen.

Conditions

• Relapsed or Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Selinexor	Given PO
DRUG	Homoharringtonine	Given per standard of care
DRUG	Daunorubicin	Given per standard of care
DRUG	Cytarabine	Given per standard of care
DRUG	Granulocyte Colony-Stimulating Factor	Given per standard of care
DRUG	Aclacinomycin	Given per standard of care

Timeline

• Start date: 2023-01-29
• Primary completion: 2024-12-10
• Completion: 2024-12-31
• First posted: 2023-02-13
• Last updated: 2024-10-22

Locations

1 site across 1 country: China