Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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 core-binding factor acute myeloid leukemia

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Cytarabine; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

• Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH

• In status of complete remission after one to two courses of induction therapy

• Total bilirubinic acid ≤ 35μmol/L, AST/ALT<2 times abnormal level, serum creatinine < 1.5mg/ml

• Cardiac function: EF ≥ 50%

• Hydroxyurea can be used for patient with white blood cell count ≥ 50*109/L

• ECOG (Eastern Cooperative Oncology Group) score: ≤ 2

Exclusion Criteria:

• Relapsed/refractory AML

• Serious liver/ kidney dysfunction

• Cardiac function level: 2 above

• Female in pregnancy or lactation

• With serious infection diseases or other diseases

• Not obey the principle of clinical study