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

Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02926586

Enrollment

Registered

2016-10-06

Start date

2017-01-01

Completion date

2024-07-31

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Core-Binding Factor

Keywords

RUNX1-RUNX1T1, CBFβ-MYH11, fludarabine, cytarabine

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 core-binding factor acute myeloid leukemia

Detailed 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).

Interventions

DRUGFludarabine

Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of participants with disease recurrence	one year	Comparing the percentage of participants with disease recurrence with two therapeutic regimen

Secondary

Measure	Time frame	Description
Percentage of Participants in survival	one year	Comparing the percentage of Participants in survival with two therapeutic regimen

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026