Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Decitabine

• Registration Number: NCT00358644
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-07-31
• Study First Submitted QC: 2006-07-31
• Study First Posted: 2006-08-01
• Primary Completion: 2008-02
• Study Completion: 2008-12
• Results First Submitted: 2009-04-13
• Results First Submitted QC: 2009-08-03
• Results First Posted: 2009-09-07
• Status Verified: 2010-06
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
2. Ineligible to receive intensive chemotherapy for their disease.
3. Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.

Exclusion Criteria

1. Received previous treatment for AML.
2. Previously received Vidaza.
3. Received any other investigational agents within 30 days of first dose of study drug.
4. Uncontrolled intercurrent illness.
5. Had radiotherapy within 14 days prior to study enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Decitabine	-

Primary Outcome Measures

Name	Time	Method
Complete Response = Morphologic Complete Remission (mCR)	1 year