Last updated on March 2019

Efficacy and Safety of Chidamide in CBF Leukemia


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03031262

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Recruitment Status: Open


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