AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

Study Overview
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Brief Summary
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The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with AML1-ETO acute myeloid leukemia.

Official Title
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A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia, AML1-ETO Fusion Protein Expression

Intervention / Treatment
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* Drug: Fludarabine
* Drug: Cytarabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen ECOG (Eastern Cooperative Oncology Group) score: <2 Exclusion Criteria: Serious liver/ kidney dysfunction Cardiac function level: 2 above Female in pregnancy or lactation With serious infection diseases or other diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Fludarabine<br>The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously. | Drug: Fludarabine<br>* 50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4<br>* Other names: Fludara;Drug: Cytarabine<br>* 2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4<br>* Other names: Cytosar;|
| Active Comparator: HD-Arac<br>The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously. | Drug: Cytarabine<br>* 2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4<br>* Other names: Cytosar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with disease recurrence |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in survival |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myeloid leukemia,, AML1-ETO fusion protein,, Fludarabine,, recurrence