Chidamide Plus DCAG for Relapsed/Refractory AML

NCT02886559 | Unknown Phase 1 DMC

• 1 other identifier: CN301-XYK-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

AML; Relapse

Keywords

demethylating agent; chidamide

Outcome Measures

Primary Outcomes (1)

• overall response rate

  3 months

Secondary Outcomes (1)

• overall survival

  1 year

Study Arms (1)

DCCAG

EXPERIMENTAL

Chidamide 30mg twice for one week decitabine 20mg/m\^2 for 5 days

Drug: Chidamide plus DCAG regimen

Interventions

Chidamide plus DCAG regimen DRUG

chidamide, decitabine, aclarubicin, cytarabine and G-CSF

Also known as: DCCAG regimen

DCCAG

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Navy General Hospital, Beijing: collaborator

Study Sites (1)

China PLA General Hospital

Beijing, 100039, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32873343 DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Yu, MD. Ph.D

  Chinese PLA General Hospital

  STUDY CHAIR

• Li-Xin Wang, MD. Ph.D.

  Navy General Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Xin Wang, MD. Ph.D.

CONTACT

086-010-66957676; wanglixin1991@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: February 14, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)