AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

Sponsor

Changhai Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02024308

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

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 AML1-ETO acute myeloid leukemia.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia AML1-ETO Fusion Protein Expression	Drug: Fludarabine Drug: Cytarabine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

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 1.4g/m2/d for 5 days intravenously.	Drug: Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4 Other Names: Fludara 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
Active Comparator: HD-Arac 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 1.4g/m2/d for 5 days intravenously.

Drug: Fludarabine

50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4

Other Names:

Fludara

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

Active Comparator: HD-Arac

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]

Secondary Outcome Measures

Percentage of Participants in survival [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia
In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
ECOG (Eastern Cooperative Oncology Group) score: <2