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non-inferiority study in efficacy and outcome between sequential treatment with low-dose cytarabine priming and hydroxyurea comparing to low dose cytarabine alone in elderly patients with acute myeloid leukemia

non-inferiority study in efficacy and outcome between sequential treatment with low-dose cytarabine priming and hydroxyurea comparing to low dose cytarabine alone in elderly patients with acute myeloid leukemia

Status
Unknown
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20201014003
Enrollment
464
Registered
2020-10-14
Start date
2020-10-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

The patients aged 60 years and over and patients were diagnosed with Acute Myeloid Leukemia according to the 2016 World Health Organization criteria.The patient was diagnosed with acute promyelocytic Non-inferiority , Low-dose cytarabine ,hydroxyurea , Acute Myeloid Leukemia

Interventions

The patients aged 60 years and over and patients were diagnosed with Acute Myeloid Leukemia according to the 2016 World Health Organization criteria.The patient was diagnosed with acute promyelocytic
RARA and the patient was assessed by the treating physician that his condition could be administered with a standard chemotherapy regimen such as ECOG less than 2&#44
cardiac ejection fraction. 50 checked by echocardiogram or MUGA
Diagnostic
Patients aged 60 years and over and patients were diagnosed with Acute Myeloid Leukemia according to

Sponsors

Siriraj Hospital Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: New patients Who were diagnosed with acute myeloid leukemia in accordance with the 2016 World Health Organization criteria and patients aged 60 and over.

Exclusion criteria

Exclusion criteria: The patient was diagnosed with acute promyelocytic leukemia with PML-RARA, the patient was assessed by the treating physician that his physical condition was able to administer standard chemotherapy drugs such as ECOG less than 2, cardiac ejection fraction greater than 50. Examined by echocardiogram or MUGA scan, patients can access drug groups. Patients with hypomethylating agent pre-treatment are within the following requirements:Serum creatinine level greater than 2 mg / dl TB level is more than 2 times normal AST / ALT level is more than 3 times the value. normal Patients with treatment plans for bone marrow transplantation Patients with sepsis Or the physician in charge of suspecting the patient has an active infection Patients with respiratory failure must use a positive pressure ventilator or intubation.

Design outcomes

Primary

MeasureTime frame
Overall survival 5 years Survival analysis and Hazard ratio

Secondary

MeasureTime frame
Incidence of Acute Myeloid Leukemia in Thailand 5 years Number AML patients per normal population

Countries

Thailand

Contacts

Public ContactWeerapat Owattanapanich

Division of Hematology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol Unive

weerapato36733@gmail.com0891081983

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026