Chidamide Plus DCAG for Relapsed/Refractory AML
Study Details
Study Description
Brief Summary
Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The investigators designed a new regimen, including chidamide, decitabine, aclarubincin, cytarabine and G-CSF, to treat rrAML.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: DCCAG Chidamide 30mg twice for one week decitabine 20mg/m^2 for 5 days |
Drug: Chidamide plus DCAG regimen
chidamide, decitabine, aclarubicin, cytarabine and G-CSF
Other Names:
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Outcome Measures
Primary Outcome Measures
- overall response rate [3 months]
Secondary Outcome Measures
- overall survival [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women whose age more than 18 and less than 59;
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Patients diagnosed as AML according to the 2008 WHO (WHO) myeloid malignant disease diagnosis standard;
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Patients who relapsed after remission or who can not achieve remission after at least two cycle of systemic therapy (including chemotherapy, hematopoietic stem cell transplantation, etc.);
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ECOG performance status 0-3;
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Expected survival time ˃ 3 months;
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Patients without serious hearts, lung, liver, kidney disease;
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Patients have not received radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation and other treatment within 4 weeks prior to the enrollment;
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Patients are able to understand and willing to sign informed consent.
Exclusion Criteria:
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Patients who allergy to the study drug or the drug with similar chemical structure;;
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Pregnancy, lactation women and women of childbearing age who do not want to practice effective methods of contraception;
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Active infection;
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Drug abuse, long-term alcohol abuse so as to affect the results of the evaluation of patients;
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Patients with mental disorders or other conditions can not obtain informed consent, can not meet the requirements of the study treatment and procedures;
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Patients have clinical significant QTc interval prolongation history (male > 450ms. Female >470ms), ventricular heart had tachycardia (VT) and atrial fibrillation (AF), II degree heart block, myocardial infarction attack (MI) within 1 year prior to the enrollment, congestive heart failure (CHF), patients of coronary heart disease who have clinical symptoms and need drug treatment.
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Cardiac ultrasound showed that the diastolic pericardial fluid dark area width ˃ 10mm;
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Patients have received organ transplantation;
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Active bleeding
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Patients have new thrombosis, embolism, cerebral hemorrhage and other diseases or medical history of patients within 1 year prior to enrollment;
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The main organs of the surgery is less than 6 weeks;
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Bone marrow hyperplasia and WBC <2.0 * 10^9/L;
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Liver function abnormalities (total bilirubin > 1.5 times of upper limit of normal range , ALT / AST > 2.5 times of the upper limit of normal range or patients with liver involvement whose ALT / AST > 1.5 times of upper limit of normal range), renal anomalies (serum creatinine > 1.5 times of upper limit of normal value );
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Not suitable for the study according to investigator's assessment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | China PLA General Hospital | Beijing | China | 100039 |
Sponsors and Collaborators
- Chinese PLA General Hospital
- Navy General Hospital, Beijing
Investigators
- Study Chair: Li Yu, MD. Ph.D, Chinese PLA General Hospital
- Principal Investigator: Li-Xin Wang, MD. Ph.D., Navy General Hospital, Beijing, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CN301-XYK-003