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

NCT ID: NCT02926586

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2024-07-31

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).

Conditions

Acute Myeloid Leukemia; Core-Binding Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Cytarabine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Cytarabine

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

Intervention Type: DRUG

Other Intervention Names

Fludara; Cytosar

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xianmin Song, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianmin Song, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang

Locations

Xianmin Song

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CBF-AML-2016

Identifier Type: -

Identifier Source: org_study_id