Spots Global Cancer Trial Database for Efficacy and Safety of Chidamide in CBF Leukemia
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Trial Identification
Brief Title: Efficacy and Safety of Chidamide in CBF Leukemia
Official Title: Efficacy and Safety of Chidamide in CBF Leukemia
Study ID: NCT03031262
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 14 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China
Contact Details
Name: Jianxiang Wang, Dr
Affiliation: Institute of Hematology & Blood Diseases Hospital, China
Role: PRINCIPAL_INVESTIGATOR
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