NCT02024308

AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• AML1-ETO Fusion Protein Expression

Interventions

Type	Name	Description
DRUG	Fludarabine	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
DRUG	Cytarabine	2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-11-01
• Completion: 2016-12-01
• First posted: 2013-12-31
• Last updated: 2013-12-31

Locations

1 site across 1 country: China