fractionated gemtuzumab ozogamicin in treating measurable residual disease in patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this phase ii trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in patients with acute myeloid leukemia. gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a chemotherapy drug, called ozogamicin. gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as cd33 receptors, and delivers a chemotherapy known as calicheamicin to kill them.

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.

Eligibility criteria:
inclusion criteria: * prior diagnosis 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). * age \>= 18 years of age * eastern cooperative oncology group (ecog) performance status =\< 3 * 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). * ability of patient to provide written informed consent. * females of childbearing potential must have a negative pregnancy test prior to receiving go. * patients who re-enroll must have achieved an mrd-negative cr during their prior enrollment 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.

Keywords: myeloid and monocytic leukemia