Recruiting
Phase 2

Gemtuzumab Ozogamicin

Sponsor:

University of Washington

Code:

NCT03737955

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemtuzumab Ozogamicin

Quality-of-Life Assessment

Bone Marrow Aspiration

Biospecimen Collection

Study Details

Brief 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.

Conditions

Acute Myeloid Leukemia

Study ID

NCT03737955

Start date

Nov 30, 2018

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (gemtuzumab ozogamicin)

Patients receive gemtuzumab ozogamicin 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. Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial.

Interventions

Gemtuzumab Ozogamicin

Receive IV

Quality-of-Life Assessment

Ancillary studies

Bone Marrow Aspiration

Undergo bone marrow aspiration

Biospecimen Collection

Undergo blood sample collection

Primary outcome measure

  • Clinical response rate [ Time Frame: Up to 70 days ]

Central Contacts and Locations

Central contacts

Mary-Elizabeth Percival

206-606-1320mperciva@fredhutch.org

Locations

Fred Hutchinson Cancer Center/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Mary-Elizabeth Percival

206-606-1320mperciva@fredhutch.org

Principal Investigator:

Mary-Elizabeth Percival

More Information

Sponsor

University of Washington

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Myeloid and Monocytic Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-08-13.