Motixafortide for MRD Sensitization in AML

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07392970
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Motixafortide — DRUG
    Motixafortide is a CXCR4 inhibitor for the mobilization of hematopoietic stem progenitor cells (HSPCs) in patients undergoing autologous stem cell transplantation. It is provided as a single subcutaneous injection.

Study Details

This is a pilot phase I study evaluating the effect of motixafortide on determination of measurable residual disease (MRD) level in patients with acute myeloid leukemia (AML) who have completed induction treatment. Consenting and eligible patients will undergo standard of care (SOC) bone marrow and peripheral blood assessments with SOC MRD assays, followed by a single injection of motixafortide. Ten to 14 hours after injection, the patient will undergo peripheral blood collection for the same applicable MRD tests

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jun 2, 2028
Completion
Dec 2, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Motixafortide Injection
    Consenting and eligible patients will bone marrow and peripheral blood testing assessments along with measurable residual disease (MRD) assays. Following completion of assessments, patients will receive a single injection of Motixafortide. The following day, 10-14 hours after the injection, patients will repeat the peripheral blood testing for MRD tests. Investigators will follow up with patients every 4 months for 18 months after study treatment.

Primary Outcome Measure

Efficacy of motixafortide on measurable residual disease (MRD) levels [ Time Frame: Day 1 before motixafortide and Day 2 (estimated total time is 2 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Samuel Urrutia, MD
[email protected]
314-273-6734
Samuel Urrutia, MD (PRINCIPAL_INVESTIGATOR)
John F DiPersio, MD, PhD (SUB_INVESTIGATOR)
Feng Gao, MD, PhD, MPH (SUB_INVESTIGATOR)
Ningying Wu, MD, PhD (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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