Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Condition: 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
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Autologous Bone Marrow Transplantation; Autologous Hematopoietic Stem Cell Transplantation; Busulfan; Cytarabine; Daunorubicin Hydrochloride; Decitabine; Etoposide; Filgrastim; Laboratory Biomarker Analysis; Pharmacological Study
Intervention description: Undergo autologous bone marrow transplantation; Undergo autologous PBSC transplantation; Given IV; Given IV; Given IV; Given IV; Given IV; Given SC; Correlative studies; Correlative studies
Intervention MeSH terms: Cytarabine; Etoposide; Podophyllotoxin; Daunorubicin; Etoposide phosphate; Busulfan; Decitabine; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 546.0
Sex: All
Minimum age: 15 Years
Maximum age: 59 Years
Healthy volunteers: No

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 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 criteria:

        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