Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome or High-Risk Myeloproliferative Neoplasm

OUTLINE:

Patients receive gemtuzumab ozogamicin intravenously (IV) on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1.

After completion of study treatment, patients are followed up for 6 months.

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Myeloproliferative Neoplasm

• Drug: Gemtuzumab Ozogamicin
  Receive IV
  Other Names:

  • CDP-771
  • Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody
  • Mylotarg
• Other: Quality-of-Life Assessment
  Ancillary studies
  Other Name: Quality of Life Assessment

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 study requirements.

• National Cancer Institute (NCI)
• Pfizer