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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT02926586

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Core-Binding Factor	Drug: Fludarabine Drug: Cytarabine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Aug 16, 2020

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Other Names: Fludara
Active Comparator: high-dose 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.	Drug: Cytarabine 2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4 Other Names: Cytosar

Arm

Intervention/Treatment

Experimental: 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.

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

Other Names:

Fludara

Active Comparator: high-dose 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.

Drug: Cytarabine

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

Other Names:

Cytosar

Outcome Measures

Primary Outcome Measures

Percentage of participants with disease recurrence [one year]
Comparing the percentage of participants with disease recurrence with two therapeutic regimen

Secondary Outcome Measures

Percentage of Participants in survival [one year]
Comparing the percentage of Participants in survival with two therapeutic regimen

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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