This phase II trial tests how well motixafortide works on determining measurable residual disease (MRD) level in patients with acute myeloid leukemia (AML) after completion of treatment. One of the ways doctors monitor the status of disease like AML is by looking in the bone marrow for “measurable residual disease,” or MRD. Unfortunately, sometimes people who do not have MRD relapse anyway. Some researchers think that, because of how the MRD testing is done (by drawing a small amount of bone marrow from a person’s hip), it’s possible that there are other sites in the body where disease still exists even when the testing does not show MRD. Motixafortide helps stem cells move from the bone marrow to the blood so they can be collected. Researchers want to see if the drug motixafortide, when given to people whose AML is in complete remission, can expose disease that is still present.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07392970.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Approved
Contact: Samuel Urrutia Argueta
Phone: 314-273-6734
PRIMARY OBJECTIVE:
I. To evaluate the effect of motixafortide in patients with AML in complete remission (CR) on determination of MRD level.
SECONDARY OBJECTIVES:
I. To assess the ability of motixafortide to sensitize MRD detection in AML in CR after therapy.
II. To determine the sensitivity of next generation sequencing (NGS) and flow cytometry assessments for MRD between bone marrow, peripheral blood, and motixafortide-sensitized peripheral blood samples.
III. To evaluate relapse-free survival (RFS).
IV. To determine the time between MRD testing and next line of therapy.
V. To evaluate overall survival (OS).
EXPLORATORY OBJECTIVES:
I. To explore the relationship between CXC chemokine receptor 4 (CXCR) AML blast expression and MRD expression.
II. To explore the relationship between sensitized MRD and relapse or death.
III. To explore the relationship between MRD, motixafortide-sensitized MRD, and disease burden.
OUTLINE:
Patients receive motixafortide subcutaneously (SC) over 2 minutes on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection on study.
After completion of study treatment, patients are followed up every 4 weeks for 18 months.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorSamuel Urrutia Argueta
