Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML

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 core-binding factor acute myeloid leukemia

Detailed Description
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The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).

Official Title
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Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study

Conditions
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Acute Myeloid Leukemia, Core-Binding Factor

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 CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH In status of complete remission after one to two courses of induction therapy Total bilirubinic acid ≤ 35μmol/L, AST/ALT<2 times abnormal level, serum creatinine < 1.5mg/ml Cardiac function: EF ≥ 50% Hydroxyurea can be used for patient with white blood cell count ≥ 50*109/L ECOG (Eastern Cooperative Oncology Group) score: ≤ 2 Exclusion Criteria: Relapsed/refractory AML Serious liver/ kidney dysfunction Cardiac function level: 2 above Female in pregnancy or lactation With serious infection diseases or other diseases Not obey the principle of clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 1500mg/m2/d for 5 days intravenously. | Drug: Fludarabine<br>* Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4<br>* Other names: Fludara;|
| Active Comparator: high-dose cytarabine<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 | Comparing the percentage of participants with disease recurrence with two therapeutic regimen | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in survival | Comparing the percentage of Participants in survival with two therapeutic regimen | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RUNX1-RUNX1T1, CBFβ-MYH11, fludarabine, cytarabine