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

Phase 4

Completed

• Conditions: Acute Myeloid Leukemia; Core-Binding Factor
• Interventions: Drug: Cytarabine; Drug: Fludarabine

• Registration Number: NCT02926586
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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).

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Study Start: 2017-01-01
• Primary Completion: 2020-08-16
• Study Completion: 2024-07
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-dose cytarabine	Cytarabine	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.
Fludarabine	Fludarabine	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with disease recurrence	one year	Comparing the percentage of participants with disease recurrence with two therapeutic regimen

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants in survival	one year	Comparing the percentage of Participants in survival with two therapeutic regimen

Trial Locations

Locations (1)

Xianmin Song; 🇨🇳 Shanghai, Shanghai, China