Phase II Study of Maintenance Therapy with Decitabine (NSC #127716, IND #50733) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients with AML < 60 years
Trial Description
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.
Eligibility Requirements
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