Actively Recruiting
Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia
Led by University of Washington · Updated on 2026-01-28
36
Participants Needed
1
Research Sites
421 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior diagnosis of acute myeloid leukemia based on 2016 World Health Organization criteria (excluding acute promyelocytic leukemia and biphenotypic AML)
- Measurable residual disease only with complete response or incomplete hematologic recovery status per 2017 European Leukemia Net criteria
- Measurable residual disease confirmed by multiparameter flow cytometry, PCR-based molecular markers, or karyotypic markers
- Received at least one cycle of standard induction chemotherapy prior to enrollment
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- AML blasts must express CD33
- Serum creatinine less than or equal to 2.0 mg/dL for adults
- Total bilirubin less than or equal to 2 times the institutional upper limit of normal for age (unless Gilbert's disease is present)
- AST and ALT less than 2.5 times the institutional upper limit of normal for age (unless related to resolving infections)
- Ability to provide written informed consent
- Females of childbearing potential must have a negative pregnancy test prior to receiving study treatment
- Patients who re-enroll must have achieved measurable residual disease-negative complete remission during prior enrollment
You will not qualify if you...
- Chemotherapy or radiation therapy within 14 days before entering the study
- Receiving other investigational agents
- Uncontrolled or concurrent illness including uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutchinson Cancer Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Mary-Elizabeth Percival
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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