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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Core-Binding Factor; Acute Myeloid Leukemia

Treatments: Drug: Fludarabine; Drug: Cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02926586

CBF-AML-2016

Details and patient eligibility

About

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

Full description

The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).

Enrollment: 68 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Fludarabine

Experimental group

Description:

The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1500mg/m2/d for 5 days intravenously.

Treatment:

Drug: Fludarabine

high-dose cytarabine

Active Comparator group

Description:

The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.

Treatment:

Drug: Cytarabine