Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients
The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy.
Primary: Safety and tolerability of the decitabine regimen in the post remission state.
- Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy.
- Overall survival
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients Who Can Tolerate Aggressive Therapy|
- Primary: Safety and tolerability of the decitabine regimen in the post remission state. [ Time Frame: 18 mos on treatment and one year followup thereafter ] [ Designated as safety issue: Yes ]
Patient will come to the infusion center for a one-hour infusion on three (3) consecutive days during a 28-day cycle. The 28-day cycle will be repeated for up to 18 months if tolerated or there is no evidence of loss of remission. Patient will receive maintenance therapy with the study drug Decitabine.
The Long-Term Follow-Up Schedule begins from the end of treatment. All patients who receive at least one dose of study drug will be followed for a minimum of one year. The maximum follow-up for all patients will be 5 years from the date of last enrolled patient.
- 1- Disease-free survival - [ Time Frame: One Year ] [ Designated as safety issue: No ]To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Dectiabine as post-consolidation maintenance therapy.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: All patients
All participants enrolled.
Drug: Decitabine (Dacogen)
Decitabine; 20 mg/m2; 1 hour intravenous infusion; 1 -3 days (will be given on a 28-day cycle for up to 18 months)
Other Name: Dacogen (NDA 021790)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01149408
|United States, Utah|
|University of Utah, Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Paul J Shami, MD||University of Utah|