AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
Conditions
Acute Myeloid Leukemia - AML1-ETO Fusion Protein Expression
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
acute myeloid leukemia,, AML1-ETO fusion protein,, Fludarabine,, recurrence
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Fludarabine Type: Drug
Name: Cytarabine Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Department of Hematology, Changhai Hospital
Shanghai, China
Status: Recruiting
Contact: Xianmin Song - 86-21-31161285 - shongxm@gmail.com
Start Date
November 2010
Completion Date
December 2016
Sponsors
Changhai Hospital
Source
Changhai Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page