Overview

Efficacy and Safety of Chidamide in CBF Leukemia

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Institute of Hematology & Blood Diseases Hospital

Treatments:

Cytarabine

Criteria

Inclusion Criteria:

1. Age of 14 to 55 years old;

2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL
subtypes) and with AML1-ETO or CBF-MYH11 mutation.

3. Reached CR after induction regimen.

4. ECOG score of ≤ 2;

5. Patients with eligible laboratory examination including liver,renal and heart
function.

6. Adult patients are willing to participate in the study and sign the informed consent
by themselves or by their immediate family. Patients under 18 years old willing to
participate should have their legal guardians sign the informed consent.

Exclusion Criteria:

1. Secondary leukemia.

2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy
in the last 6 months due to other tumor.

3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However,
patients with abnormal blood count, but with undiagnosed MDS or MPD patients are
included.

4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;

5. With BCR-ABL fusion gene;

6. Pregnant or lactating women;

7. With ineligible renal or liver function;

8. With active cardiovascular disease;

9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;

10. AIDS;

11. Patients had central nervous system involvement when they were diagnosed as AML.

12. Patients with epilepsy or dementia or other mental disease who couldn't understand or
follow the research.

13. Drugs, medical, mental or social situation may distract patients from following the
research or being evaluated the results.

14. Patients with other factors which were considered unsuitable to participate in the
study by the investigators.