Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome or High-Risk Myeloproliferative Neoplasm

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome or high-risk myeloproliferative neoplasm. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Calicheamicins; Gemtuzumab

Criteria

Inclusion Criteria:

• Prior diagnosis of either high-risk myelodysplastic syndrome (myelodysplastic syndrome [MDS]; defined as >= 10% blasts in bone marrow or blood), high-risk myeloproliferative neoplasms (myeloproliferative neoplasms [MPN]; defined as >= 10% blasts in bone marrow or blood), or 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.

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.