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AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

Information source: Changhai Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia; AML1-ETO Fusion Protein Expression

Intervention: Fludarabine (Drug); Cytarabine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Changhai Hospital

Official(s) and/or principal investigator(s):
Xianmin Song, Doctor, Principal Investigator, Affiliation: Department of Hematology, Changhai Hospital

Overall contact:
Xianmin Song, Doctor, Phone: 83-21-31161285, Email: shongxm@gmail.com


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of participants with disease recurrence

Secondary outcome: Percentage of Participants in survival


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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 and Contacts

Xianmin Song, Doctor, Phone: 83-21-31161285, Email: shongxm@gmail.com

Department of Hematology, Changhai Hospital, Shanghai 200433, China; Recruiting
Xianmin Song, Phone: 86-21-31161285, Email: shongxm@gmail.com
Xianmin Song, Principal Investigator
Additional Information

Starting date: November 2010
Last updated: December 27, 2013

Page last updated: August 20, 2015

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