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

Official record

Identifier

NCT03737955

Recruiting locations

country

United States

Interventions studied

Gemtuzumab OzogamicinQuality-of-Life AssessmentBone Marrow AspirationBiospecimen Collection

Lead sponsor

University of Washington

Target enrolment

36 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Nov 13, 2018

Last updated on the registry

Aug 13, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Leukemia