Chidamide Plus DCAG for Relapsed/Refractory AML

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 Overview

• Status: Unknown
• Conditions: AML; Relapse
• Intervention / Treatment: Drug: Chidamide plus DCAG regimen

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Li-Xin Wang, MD. Ph.D.; Phone Number: 086-010-66957676; Email: wanglixin1991@sohu.com

Study Locations

• China
  • Beijing, China, 100039
    • Recruiting
    • China PLA General Hospital
    • Contact: Li Yu, M.D Ph.D; Phone Number: 010-66937644; Email: chunhuiliyu@yahoo.com
    • Principal Investigator: Li-Xin Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: DCCAG regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall response rate	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	1 year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: 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

Publications and helpful links

General Publications

• Wang L, Luo J, Chen G, Fang M, Wei X, Li Y, Liu Z, Zhang Y, Gao S, Shen J, Wang X, Gao X, Zhou W, Ma Y, Liu H, Li X, Yang L, Sun K, Yu L. Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study. Clin Epigenetics. 2020 Sep 1;12(1):132. doi: 10.1186/s13148-020-00923-4.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: chidamide; demethylating agent
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: CN301-XYK-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES