Status:
COMPLETED
Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Eligibility:
All Genders
15-59 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leu...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the efficacy, feasibility, and toxicities when one year of maintenance therapy with decitabine is given to patients \< 60 years with untreated acute myeloid leukem...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Unequivocal histologic diagnosis of AML (\> 20% blasts in the bone marrow based on the World Health Organization \[WHO\] and/or French American British \[FAB\] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there were no bone marrow biopsy showing myelodysplastic syndrome (MDS) \> 3 months prior to enrollment; patients with therapy-related AML are eligible if they have been free of their primary disease and have not received any chemotherapy for at least 2 years
- No prior 5-azacitidine or decitabine therapy
- No prior treatment for leukemia or myelodysplastic syndrome with four permissible exceptions:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
- Growth factor/cytokine support
Exclusion
Key Trial Info
Start Date :
November 15 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT00416598
Start Date
November 15 2006
End Date
December 1 2016
Last Update
February 19 2019
Active Locations (46)
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1
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
2
Beebe Medical Center
Lewes, Delaware, United States, 19958
3
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
4
Florida Hospital Orlando
Orlando, Florida, United States, 32803