Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse
Recruiting now · Phase 1/Phase 2
Conditions studied: Leukemia, Myeloid, Acute
In brief
The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.
Key facts
- Study ID
- NCT05270200
- Run by
- Zhujiang Hospital
- People needed
- 40
- Starts
- 2022-02-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1.Age 18 to 60 years old,both male and female
- 2.Be able to understand and sign informed consent
- 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic
- 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML
- 5.Patients with an ECOG performance status 0,1,2 or 3
- 6.Expected survival time ≥ 3 months
- 7.Non-hematological toxicity related to transplantation does not exceed Grade 2
- 8.Laboratory indicators meet the following standards:
- 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.
- Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment.
- Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion.
- Serum creatinine clearance rate is greater than 30ml/min.
You may not qualify if…
- 1.Uncontrollable active infection
- 2.Patients with active hepatitis B or C or HIV infection before enrollment
- 3.Have a grade III-IV graft-versus-host disease
Where it is running
- Nanfang Hospital of Southern Medical University — Guanzhou, Guandong, China (enrolling)
Full record on ClinicalTrials.gov
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