Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Gemtuzumab Ozogamicin (Drug): Receive IV
• Quality-of-Life Assessment (Other): Ancillary studies
• Bone Marrow Aspiration (Procedure): Undergo bone marrow aspiration
• Biospecimen Collection (Procedure): Undergo blood sample collection

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• bone marrow: Part of the study plan
• blood samples: Part of the study plan
• questionnaires: Part of the study plan

Main goals

• Clinical response rate (Up to 70 days)

Other goals

• Rate of sinusoidal obstructive syndrome (SOS)
• Rate of allogeneic hematopoietic cell transplantation (HCT)

Planned enrollment: 36 (estimated).

• Fred Hutchinson Cancer Center/University of Washington Cancer Consortium, Seattle, Washington

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT03737955

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 12, 2026. Public record; not medical advice.