Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

Conditions
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AML

Intervention / Treatment
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* Drug: Daunomycin and Cytarabine (DA Regimen)
* Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 14 to 55 years old; Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes). ECOG score ≤ 2; Patients with eligible laboratory examination including liver,renal and heart function. 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: Patients who had received induction therapy. Secondary leukemia. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor. 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. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients; With BCR-ABL fusion gene; Pregnant or lactating women; AML with ineligible renal or liver function; AML with active cardiovascular disease; Severe infection disease including uncured tuberculosis pulmonary aspergillosis; AIDS; Patients had central nervous system involvement when they were diagnosed as AML. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results. Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DA Regimen<br>Patients receive standard DA induction regimen including daunomycin and cytarabine. | Drug: Daunomycin and Cytarabine (DA Regimen)<br>* Cytarabine at a dose of 100mg/㎡/d on day 1-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.<br>* Other names: Daunomycin and Cytarabine;|
| Experimental: Intermediate Dose of DA Regimen<br>Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine. | Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)<br>* 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.<br>* Other names: Daunomycin and Cytarabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rate (OS) | OS is defined as the time from the date of randomization until the date of death from any cause. | Within 5 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission Rate |  | Within 2 months after randomization | 
| Event-Free Survival Rate |  | Within 5 years after randomization | 
| Relapse-Free Survival Rate (RFS) |  | Within 5 years after randomization | 
| Cumulative incidence of relapse |  | Within 5 years after randomization | 
| Early Mortality |  | within 45 days after randomization |