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Clinical study of the combination of decitabine with low- dose idarubicin /cytarabine in AML envolving from MDS and MDS-RAEB

Clinical study of the combination of decitabine with low- dose idarubicin /cytarabine in AML envolving from MDS and MDS-RAEB

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15005771
Enrollment
Unknown
Registered
2014-12-23
Start date
2013-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

AML envolving from MDS, MDS-RAEB

Interventions

Case series:decitabine with low-dose idarubicin / cytarabine

Sponsors

1st Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults more than 18 years of age; 2. Patients with a confirmed diagnosis of de novo acute myeloid leukemia (AML) envolving from MDS, or MDS-RAEB-1 acompanied with complex chromosomal aberrations, or MDS-RAEB-2, or patients with AML envolving from MDS / MDS-RAEB received no more than 2 kinds of schemes of first recurrence; 3. Patients with adequate performance status (Eastern Cooperative Oncology Group scale less than 2); 4. Adequate hepato-renal function (creatinine level less than 176umol/l; bilirubin level less than 50umol/L and hepatic enzymes less than twice the upper limit of normal); 5. Patients are required to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients also have other organ malignant tumor; 2. Patient's liver and kidney function was abnormal beyond the inclusion criteria; 3. Patients have serious heart disease, including myocardial infarction, heart function grade 3-4; 4. Known HIV positive serological reaction; 5. Life expectancy is less than 3 months; 6. Patients had received treatment with Vidaza or decitabine, or had received stem cell transplantation; 7. Pregnant or lactating women; 8. The bone marrow biopsy showed low proliferative MDS; 9. Diagnosed with secondary MDS; 10. Participating in other clinical research in the same period; 11. the researchers estimate cannot enter group.

Design outcomes

Primary

MeasureTime frame
complete remission rate after first chemotherapy cycle;

Secondary

MeasureTime frame
partial remission rate;two years overall survival rate;

Contacts

Public ContactHong-yan Tong
xing_nong@163.com+86 13958122357

Outcome results

None listed

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