AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

Phase 4

• Conditions: Acute Myeloid Leukemia; AML1-ETO Fusion Protein Expression
• Interventions: Drug: Fludarabine; Drug: Cytarabine

• Registration Number: NCT02024308
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-27
• Last Update Submitted: 2013-12-27
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31
• Primary Completion: 2015-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

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Exclusion Criteria

• Serious liver/ kidney dysfunction
• Cardiac function level: 2 above
• Female in pregnancy or lactation
• With serious infection diseases or other diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fludarabine	Fludarabine	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.
Fludarabine	Cytarabine	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.
HD-Arac	Cytarabine	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with disease recurrence	one year

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants in survival	one year

Trial Locations

Locations (1)

Department of Hematology, Changhai Hospital; 🇨🇳 Shanghai, China