Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Completed · Phase 2
Conditions studied: Acute Myeloid Leukemia, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Untreated Adult Acute Myeloid Leukemia
In brief
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 leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.
Key facts
- Study ID
- NCT00416598
- Run by
- National Cancer Institute (NCI)
- People needed
- 546
- Starts
- 2006-11-15
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2019-02-19
Who can join
Age: 15 and older, up to 59. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- UCSF Medical Center-Mount Zion — San Francisco, California, United States
- Beebe Medical Center — Lewes, Delaware, United States
- Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
- Florida Hospital Orlando — Orlando, Florida, United States
- Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
- University of Illinois — Chicago, Illinois, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
- Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
- Eastern Maine Medical Center — Bangor, Maine, United States
- University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Union Hospital of Cecil County — Elkton, Maryland, United States
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Commonwealth Hematology Oncology PC-Worcester — Worcester, Massachusetts, United States
- Veterans Administration — Columbia, Missouri, United States
- University of Missouri - Ellis Fischel — Columbia, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Great Plains Health Callahan Cancer Center — North Platte, Nebraska, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- University Medical Center of Southern Nevada — Las Vegas, Nevada, United States
- Nevada Cancer Research Foundation CCOP — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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