AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02024308
• Other study ID #: CHXY-AML01
• Status: Unknown status
• Phase: Phase 4
• First received: December 20, 2013
• Last updated: December 27, 2013
• Start date: November 2010
• Est. completion date: December 2016

Study information

• Verified date: December 2013
• Source: Changhai Hospital
• Contact: Xianmin Song, Doctor
• Phone: 83-21-31161285
• Email: shongxm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• AML1-ETO Fusion Protein Expression
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
China	Department of Hematology, Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with disease recurrence		one year
Secondary	Percentage of Participants in survival		one year