Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 3
Started
2017-02-08
Last updated
2025-05-30
Condition(s) studied
AML
Investigational drug(s) / intervention(s)
Daunomycin and Cytarabine (DA Regimen)Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)
Daunomycin and Cytarabine (DA Regimen): Cytarabine at a dose of 100mg/㎡/d on day 1-7.
Daunomycin at a dose of 60mg/㎡/d on day 1-3.
Daunomycin and Cytarabine (Intermediate Dose of DA Regimen): Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7.
Daunomycin at a dose of 60mg/㎡/d on day 1-3.
Study summary
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
Eligibility
Sex
ALL
Min age
14 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age of 14 to 55 years old;
2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
3. ECOG score ≤ 2;
4. Patients with eligible laboratory examination including liver,renal and heart function.
5. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.
Exclusion Criteria:
1. Patients who had received induction therapy.
2. Secondary leukemia.
3. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
4. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
5. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
6. With BCR-ABL fusion gene;
7. Pregnant or lactating women;
8. AML with ineligible renal or liver function;
9. AML with active cardiovascular disease;
10. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
11. AIDS;
12. Patients had central nervous system involvement when they were diagnosed as AML.
13. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
14. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
15. Patients with other factors which were considered unsuitable to participate in the study by the investigators.
Primary outcome measure(s)
Overall Survival Rate (OS) — Within 5 years after randomization OS is defined as the time from the date of randomization until the date of death from any cause.
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology & Blood Diseases Hospital
Tianjin
Tianjin Municipality
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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