Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title: An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Status Completed

Clinical Trial Summary

The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.

Clinical Trial Description

The objectives of this trial are:

• To generate additional information about the overall safety profile,

• To generate safety information of hepatically or renally impaired patients, as appropriate, and

• To generate safety information when patients are also taking concomitant medications and/or therapies without trial restrictions when decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with MDS or AML (≥ 30% blasts).

The purpose of this open-label, expanded-access trial is to provide decitabine to patients with AML or MDS who have completed participation per protocol in the DACO-018 study and for whom continuation of treatment with decitabine is indicated, per the opinion of the investigator. In order to continue treatment with decitabine, at a minimum, there must be no disease progression while the patient was participating in the DACO-018 trial and during the period after the patient discontinued from the DACO-018 study and before entering this trial. Patients must enroll in this trial within 8 weeks of discontinuing from the DACO-018 study and not have received any other chemotherapy for their disease during this interim period.

Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT00760084
• Study type: Interventional
• Source: Eisai Inc.
• Status: Completed
• Phase: Phase 2
• Start date: July 2005
• Completion date: February 2008