Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Active, not recruiting; Phase 3

Conditions: AML

Treatments: Drug: Daunomycin and Cytarabine (DA Regimen); Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)

Study type: Interventional

Funder types: Other

Identifiers

NCT03021330

IIT2016007（Cytarabine）

Details and patient eligibility

About

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.

Full description

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 at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 14 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

DA Regimen

Active Comparator group

Description:

Patients receive standard DA induction regimen including daunomycin and cytarabine.

Treatment:

Drug: Daunomycin and Cytarabine (DA Regimen)

Intermediate Dose of DA Regimen

Experimental group

Description:

Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine.

Treatment:

Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)