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A randomized controlled trial for azacytidine combined with Standard induction chemotherapy regimen (daunorubicin+cytarabine) in the treatment of adult acute myeloid leukemia / high risk myelodysplastic syndrome

A randomized controlled trial for azacytidine combined with Standard induction chemotherapy regimen (daunorubicin+cytarabine) in the treatment of adult acute myeloid leukemia / high risk myelodysplastic syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023700
Enrollment
Unknown
Registered
2019-06-08
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Acute myeloid leukemia/high risk myelodysplastic syndrome

Interventions

Experimental group:Azacitidine + daunorubicin + cytarabine
Control group:daunorubicin + cytarabine

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old; 2. AML: including newly diagnosed AML, secondary AML (including MDS/MPN transformed AML, treatment-related AML), relapsed refractory AML; 3. MDS-EB: including MDS-EB1 and MDS-EB2.

Exclusion criteria

Exclusion criteria: 1. Severe liver and kidney dysfunction, cardiac insufficiency; 2. Uncontrolled infectious diseases; 3. Patients were not remission after 2 courses of treatment or hematopoietic stem cell transplantation was removed during treatment; 4. Patients who were participating in other clinical trials; 5. Other condition that the investigators believes are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
complete remission rate;complete remission with partial hematological remission;Relapse-free survival;2-years overall survival;—

Countries

China

Contacts

Public ContactGong Yuping

Department of Hematology, West China Hospital, Sichuan University

gongyuping@hotmail.com+86 18980601257

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026