Chidamide Plus DCAG for Relapsed/Refractory AML

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02886559
Collaborator
Navy General Hospital, Beijing (Other)
100
1
1
36
2.8

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chidamide plus DCAG regimen
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. overall response rate [3 months]

    Secondary Outcome Measures

    1. overall survival [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Li Yu, Professor, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT02886559
    Other Study ID Numbers:
    • CN301-XYK-003
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Feb 14, 2018
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Li Yu, Professor, Chinese PLA General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2018