Using gemtuzumab ozogamicin to treat residual disease in acute myeloid leukemia
A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)
This study is testing if a new targeted treatment called gemtuzumab ozogamicin can help people with acute myeloid leukemia who still have leftover cancer after initial therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | chemotherapy, radiation, gemtuzumab |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT03737955 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with acute myeloid leukemia who have measurable residual disease after initial chemotherapy.
Not a fit: Patients with acute promyelocytic leukemia or those who do not meet the criteria for measurable residual disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with residual disease after standard chemotherapy for acute myeloid leukemia.
How similar studies have performed: Other studies have shown promise with similar targeted therapies in treating acute myeloid leukemia, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.