Leukemia, Myeloid, Acute Clinical Trial
Official title:
To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation:A Multicenter, Single-arm Study
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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: 1. 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. 2. 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. 3. 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. 4. Serum creatinine clearance rate is greater than 30ml/min. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Nanfang Hospital of Southern Medical University | Guanzhou | Guandong |
Lead Sponsor | Collaborator |
---|---|
Zhujiang Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Paticipants With Adverse Events as a Measure of Safety | Safety were measured with respect to:
Safety measurements Incidence of adverse events |
From the day of stem cell transplantation to one year after stem cell transplantation | |
Primary | One year cumulative incidence of relapse | Leukemia relapse base on morphoogy criterion | From the day of stem cell transplantation to one year after stem cell transplantation | |
Secondary | Relapes-free Survival(RFS) | The time that a participant survives without relapes of the disease | From the day of stem cell transplantation to one year after stem cell transplantation | |
Secondary | Overall survival(OS) | The time that a participant survives without death | From the day of stem cell transplantation to one year after stem cell transplantation | |
Secondary | The cumulative Incidence rate of GVHD | acute GVHD and chronic GVHD diagnosis based on MIH criterion | From the day of stem cell transplantation to one year after stem cell transplantation |
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