Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients
|ClinicalTrials.gov Identifier: NCT01149408|
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : October 7, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia AML||Drug: Decitabine (Dacogen)||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients Who Can Tolerate Aggressive Therapy|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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)
- Primary: Safety and tolerability of the decitabine regimen in the post remission state. [ Time Frame: 18 mos on treatment and one year followup thereafter ]
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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|