Using gemtuzumab ozogamicin to treat residual disease in acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of fractionated gemtuzumab ozogamicin in treating measurable residual disease in patients with acute myeloid leukemia (AML). Gemtuzumab ozogamicin is a targeted therapy that combines a monoclonal antibody with a chemotherapy drug to specifically attack cancer cells expressing CD33 receptors. Patients will receive the treatment intravenously over a period of 35 days, with the possibility of a second course if they respond well and do not experience significant side effects. The study aims to assess the treatment's impact on disease progression and patient quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Mary-Elizabeth Percival — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Mary-Elizabeth Percival
• Email: mperciva@fredhutch.org
• Phone: 206-606-1320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.