Clinical efficacy and MRD monitoring of relapse prevention of decitabine containing induction chemotherapy in de novo AML: a multi-center, prospective, randomized controlled study

Clinical efficacy and minimal residual disease monitoring of relapse prevention of decitabine containing induction chemotherapy in de novo acute myeloid leukemia study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037928

Enrollment

Unknown

Registered

2020-09-04

Start date

2020-09-15

Completion date

Unknown

Last updated

2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

Trial group:decitabine+IA chemotherapy

Control group:IA chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 14-60 years; 2. Diagnosis of AML (non APL) patients who meet who 2008 or 2016 standards; 3. Patients who have not been treated with induction chemotherapy; 4. Patients with ECoG score <= 2; 5. The patients who signed the informed consent of the subjects.

Exclusion criteria

Exclusion criteria: 1. Patients with MDS transformation, secondary AML or other blood system diseases; 2. Patients with central nervous system invasion; 3. Patients with the allergy to decitabine; 4. Patients with other serious diseases, such as myocardial infarction, severe or unstable angina pectoris, serious arrhythmia, cerebrovascular events (including transient cerebral ischemia), etc.

Design outcomes

Primary

Measure	Time frame
Remission rate;MRD negative rate;	—

Secondary

Measure	Time frame
Overal survival;Relapse free survival;	—

Countries

China

Contacts

Public ContactZhang Donghua

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

zdh_62@126.com+86 27 83662830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026