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

STATUS

Recruiting
End date

Jun 1, 2024
participants needed

36
sponsor

University of Washington

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Updated on 19 April 2022

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cancer

remission

myeloid leukemia

flow cytometry

monoclonal antibodies

leukemia

gilbert's syndrome

induction chemotherapy

residual tumor

gemtuzumab

acute promyelocytic leukemia

blast cells

gemtuzumab ozogamicin

PCR test

tumor cells

monoclonal protein

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.

Description

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.

Details

Condition	Acute Myeloid Leukemia
Treatment	quality-of-life assessment, gemtuzumab ozogamicin
Clinical Study Identifier	NCT03737955
Sponsor	University of Washington
Last Modified on	19 April 2022

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Eligibility		Yes	No	Not Sure
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). Pediatric patients (2-18 years of age) must have MRD positivity during/after consolidation or post-transplant
	Age >= 2 years of age
	Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (for adults) or Lansky performance status >= 40 (for children)
	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)
	For children (< 18 years of age): Glomerular filtration rate (GFR) in ml/min (age 2: 63-175; age 3-12: 89-165; females 13 and older: 75-115; males 13 and older: 85-125)
	For children (< 18 years of age): Total bilirubin =< 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease)
	For children (< 18 years of age): AST and ALT < 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications)
	Ability of patient or representative 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

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