NCT05951855

Study of Selinexor Combined With Chidamide in Relapsed/Refractory Acute Leukemia (AML) Patients

Selinexor in Combination With Chidamide in Unfit Relapsed/Refractory Acute Leukemia: a Phase 2, Single-Arm, Open-Label, Multi-Center Prospective Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor combined with chidamide in the treatment of unfit R/R AML.

Detailed description

This protocol corresponds to a multicenter, open-label, single arm, prospective study designed to determine the efficacy and safety of selinexor in combination with chidamide for unfit R/R AML. Selinexor will be given orally at 40 or 60mg on d1,4,8,11; Chidamide will be given orally at 10mg on d1-28; 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. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years. Study design allows 42 patients.

Conditions

• Acute Myeloid Leukemia (Relapsed/Refractory)

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor 60mg/day, weight≥70kg (40mg/day, weight\<70kg) orally on d1,4,8,11,
DRUG	Chidamide	Chidamide 10mg/day, orally on day 1 to 28

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-09-01
• Completion: 2025-03-01
• First posted: 2023-07-19
• Last updated: 2023-07-19

Locations

1 site across 1 country: China