Overview

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.