Efficacy and Safety of Chidamide in CBF Leukemia

NCT03031262 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: IIT2016007（Chidamide）
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.

Conditions

AML

Outcome Measures

Primary Outcomes (1)

• Relapse-Free Survival Rate (RFS)

  RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for CBF positive leukemia patients who achieve CR.

  Within 5 years after randomization

Secondary Outcomes (3)

• Non-relapse Mortality

  through treatment completion, an average of 5 months

• Overall Survival Rate (OS)

  Within 5 years after randomization

• Cumulative incidence of relapse

  Within 5 years after randomization

Study Arms (2)

High Dose of Cytarabine

ACTIVE COMPARATOR

CBF Patients who reach CR after reduction therapy receive high dose of cytarabine.

Drug: Cytarabine

HDAC + Chidamide

EXPERIMENTAL

CBF Patients who reach CR after reduction therapy receive high dose of cytarabine plus chidamide.

Drug: Cytarabine; Drug: Chidamide

Interventions

Cytarabine DRUG

Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.

Also known as: HDAC

HDAC + Chidamide; High Dose of Cytarabine

Chidamide DRUG

Chidamide at a dose of 20mg/d twice a week for 3 months.

HDAC + Chidamide

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age of 14 to 55 years old;
• Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes) and with AML1-ETO or CBF-MYH11 mutation.
• Reached CR after induction regimen.
• ECOG score of ≤ 2;
• Patients with eligible laboratory examination including liver,renal and heart function.
• Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

You may not qualify if:

• Secondary leukemia.
• Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
• Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
• Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
• With BCR-ABL fusion gene;
• Pregnant or lactating women;
• With ineligible renal or liver function;
• With active cardiovascular disease;
• Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
• AIDS;
• Patients had central nervous system involvement when they were diagnosed as AML.
• Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
• Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
• Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jianxiang Wang, Dr

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 25, 2017
• Study Start: February 8, 2017
• Primary Completion: April 10, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)