NCT03031262

Efficacy and Safety of Chidamide in CBF Leukemia

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.

Detailed description

In this open-label, randomized, prospective clinical trial, CBF AML(including AML1-ETO or CBF-MYH11 mutated patients) patients who have reached CR are randomised into two groups and receive HDAC or high dose of cytarabine plus chidamide. In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day and chidamide at a dose of 20mg/d twice a week for 3 months.Patients in control group only receive cytarabine at the same dose. The safety and efficacy of chidamide is evaluated. The primary outcome is relapse-free survival rate after treatment.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Cytarabine	Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
DRUG	Chidamide	Chidamide at a dose of 20mg/d twice a week for 3 months.

Timeline

• Start date: 2017-02-08
• Primary completion: 2025-04-10
• Completion: 2027-12-30
• First posted: 2017-01-25
• Last updated: 2025-05-30

Locations

1 site across 1 country: China