Phase 2
N=546
Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
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
Bottom Line
View on ClinicalTrials.gov: NCT00416598 ↗Enrolled (actual)
546
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Number of Participants Who Completed Maintenance Decitabine. — 62 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Bone Marrow Transplantation (Procedure); Autologous Hematopoietic Stem Cell Transplantation (Procedure); Busulfan (Drug); Cytarabine (Drug); Daunorubicin Hydrochloride (Drug); Decitabine (Drug); Etoposide (Drug); Filgrastim (Biological); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed Maintenance Decitabine. |
62 | — |
| PRIMARY Disease-free Survival (DFS) Rate at 1 Year |
80 | — |
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
Data sourced from ClinicalTrials.gov (NCT00416598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.