ABOUT THIS STUDY
- Prior diagnosis of either high-risk myelodysplastic syndrome (myelodysplastic syndrome [MDS]; defined as >= 10% blasts in bone marrow or blood), high-risk myeloproliferative neoplasms (myeloproliferative neoplasms [MPN]; defined as >= 10% blasts in bone marrow or blood), or AML based on 2016 World Health Organization criteria. Acute promyelocytic leukemia (APL) and biphenotypic AML are not eligible
- Patients must have MRD-level disease only and otherwise meet criteria for complete response (CR) or complete remission with incomplete hematologic recovery (CRi) per the 2017 European Leukemia Net response criteria (< 5% blasts in the marrow without a requirement for peripheral blood count recovery). MRD must be measurable by multiparameter flow cytometry (MPFC) and/or polymerase chain reaction (PCR)-based molecular markers and/or karyotypic markers (e.g., classical cytogenetics or fluorescence in situ hybridization). MRD status will be centrally confirmed by the UW/FHCRC clinical laboratory in order to standardize response assessment following administration of study therapy.
- Patients must have received at least 1 cycle of standard induction chemotherapy prior to enrollment on the study. However, adult patients (>= 18 years of age) are eligible for participation at any time point in treatment (after induction, during or after consolidation, pre-transplant, or post-transplant). Pediatric patients (2-18 years of age) must have MRD positivity during/after consolidation or post-transplant.
- Age >= 2 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (for adults) or Lansky performance status >= 40 (for children).
- Patient's AML blasts must have CD33 expression.
- For adults (>= 18 years of age): Serum creatinine =< 2.0 mg/dL.
- For adults (>= 18 years of age): Total bilirubin =< 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease).
- For adults (>= 18 years of age): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications).
- For children (< 18 years of age): Glomerular filtration rate (GFR) in ml/min (age 2: 63-175; age 3-12: 89-165; females 13 and older: 75-115; males 13 and older: 85-125).
- For children (< 18 years of age): Total bilirubin =< 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease).
- For children (< 18 years of age): AST and ALT < 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications).
- Ability of patient or representative to provide written informed consent.
- Females of childbearing potential must have a negative pregnancy test prior to receiving GO.
- Subjects who have had chemotherapy or radiation therapy within 14 days prior to
entering the study.
- Subjects may not be receiving other investigational agents.
- Uncontrolled or concurrent illness including, but not limited to, uncontrolled
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
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