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Efficacy and Safety of Chidamide in CBF Leukemia

NCT03031262 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-05-30

No results posted yet for this study

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

Interventions

DRUG

Cytarabine

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

DRUG

Chidamide

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

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Jianxiang Wang, Dr · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2025-04-10
Completion
2027-12-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031262 on ClinicalTrials.gov