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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02926586
• Other study ID #: CBF-AML-2016
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: July 2024

Study information

• Verified date: May 2022
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xianmin Song, Doctor
• Phone: 86-21-63240090-3932
• Email: shongxm[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: August 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Core-Binding Factor
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Fludarabine
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
• Cytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4

Locations

Country	Name	City	State
China	Xianmin Song	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with disease recurrence	Comparing the percentage of participants with disease recurrence with two therapeutic regimen	one year
Secondary	Percentage of Participants in survival	Comparing the percentage of Participants in survival with two therapeutic regimen	one year