Acute Myeloid Leukemia, AML1-ETO Fusion Protein Expression
Conditions
Keywords
acute myeloid leukemia,, AML1-ETO fusion protein,, Fludarabine,, recurrence
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.
Interventions
DRUGFludarabine
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
DRUGCytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with disease recurrence | one year |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants in survival | one year |
Countries
China
Contacts
Primary ContactXianmin Song, Doctor
Outcome results
None listed