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Clinical research for decitabine in maintenance therapy for intermediate/high-risk myelodysplastic syndrome and elderly acute myeloid leukemia.

Clinical research for decitabine in maintenance therapy for intermediate/high-risk myelodysplastic syndrome and elderly acute myeloid leukemia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021030
Enrollment
Unknown
Registered
2019-01-25
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Myelodysplastic syndrome, Elderly acute myeloid leukemia

Interventions

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Myelodysplastic syndrome diagnosed according to the 2008 WHO guidelines, IPSS scores in the intermediate-2/high-risk groups. 2. Elderly acute myeloid leukemia diagnosed according to the 2008 WHO guidelines, namely age = 65 years. 3. Liver function: serum bilirubin = 35 umol/L, AST/ALT below the upper limit of the normal value of 2 times. 4. Renal function: serum creatinine = 150 umol/L. 5. Normal heart function (NYHA 1-2). 6. Informed consent has been signed.

Exclusion criteria

Exclusion criteria: 1. Abnormal liver function: serum bilirubin > 35 umol/L, AST/ALT is greater than the upper limit of the normal value 2 times; 2. Abnormal renal function: serum creatinine > 150 umol/L; 3. Abnormal heart function (NYHA 3-4); 4. There are other organ malignant tumors; 5. Those who are active during tuberculosis; 6. HIV positive; 7. Pregnant or lactating women; 8. Those who are allergic to decitabine.

Design outcomes

Primary

MeasureTime frame
remission rate;Bone marrow cell morphology;Minimal residual disease (MRD);

Secondary

MeasureTime frame
Blood routine;coagulation function;blood biochemistry;electrocardiogram;

Countries

China

Contacts

Public ContactLiu Bei

The First Hospital of Lanzhou University

liubeiff@163.com+86 13809319379

Outcome results

None listed

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