AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

Phase 4UnknownNCT02024308

Changhai Hospital62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia AML1-ETO Fusion Protein Expression

Interventions

FludarabineDRUG

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

CytarabineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Serious liver/ kidney dysfunction * Cardiac function level: 2 above * Female in pregnancy or lactation * With serious infection diseases or other diseases

Locations (1)

Department of Hematology, Changhai Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Percentage of participants with disease recurrence

Time frame: one year

Secondary Outcomes

Percentage of Participants in survival

Time frame: one year

Central Contacts

Xianmin Song, Doctor

CONTACT

83-21-31161285 shongxm@gmail.com

Data from ClinicalTrials.gov

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