An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
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
- 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
Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for
5 consecutive days every 4 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Number of Subjects With Adverse Events
Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (< 30% blasts) or AML (> 30% blasts).
Akhil Baranwal, MD
United States: Food and Drug Administration
|Washington University School of Medicine||Saint Louis, Missouri 63110|