Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: Cytarabine; Daunorubicin

Criteria

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.