Chidamide Plus DCAG for Relapsed/Refractory AML

AML Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02886559
• Other study ID #: CN301-XYK-003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 29, 2016
• Last updated: February 12, 2018
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: September 2016
• Source: Chinese PLA General Hospital
• Contact: Li-Xin Wang, MD. Ph.D.
• Phone: 086-010-66957676
• Email: wanglixin1991[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Men and women whose age more than 18 and less than 59;

• Patients diagnosed as AML according to the 2008 WHO (WHO) myeloid malignant disease diagnosis standard;

• 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.);

• ECOG performance status 0-3;

• Expected survival time ? 3 months;

• Patients without serious hearts, lung, liver, kidney disease;

• Patients have not received radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation and other treatment within 4 weeks prior to the enrollment;

• Patients are able to understand and willing to sign informed consent.

Exclusion Criteria:

• Patients who allergy to the study drug or the drug with similar chemical structure;;

• Pregnancy, lactation women and women of childbearing age who do not want to practice effective methods of contraception;

• Active infection;

• Drug abuse, long-term alcohol abuse so as to affect the results of the evaluation of patients;

• Patients with mental disorders or other conditions can not obtain informed consent, can not meet the requirements of the study treatment and procedures;

• 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.

• Cardiac ultrasound showed that the diastolic pericardial fluid dark area width ? 10mm;

• Patients have received organ transplantation;

• Active bleeding

• Patients have new thrombosis, embolism, cerebral hemorrhage and other diseases or medical history of patients within 1 year prior to enrollment;

• The main organs of the surgery is less than 6 weeks;

• Bone marrow hyperplasia and WBC <2.0 * 10^9/L;

• 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 );

• Not suitable for the study according to investigator's assessment.

Related Conditions & MeSH terms

• AML
• Relapse

Intervention

Drug:
• Chidamide plus DCAG regimen
chidamide, decitabine, aclarubicin, cytarabine and G-CSF

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		3 months
Secondary	overall survival		1 year