NCT00760084

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Myelogenous Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Decitabine	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 myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).

Timeline

• Start date: 2005-07-01
• Primary completion: 2005-09-01
• Completion: 2008-02-01
• First posted: 2008-09-25
• Last updated: 2011-08-08
• Results posted: 2011-08-02

Locations

1 site across 1 country: United States