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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Motixafortide to boost MRD testing in AML after induction

Official title: A Pilot Clinical Trial of Motixafortide for Measurable Residual Disease (MRD) Sensitization in Acute Myeloid Leukemia (AML)

Run by Washington University School of Medicine · NCT07392970 · Data updated 2026-11-12

This study tests whether a single dose of motixafortide can change how accurately doctors measure measurable residual disease in AML patients who have finished induction therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorWashington University School of Medicine
Academic / other
Drugs / interventionschemotherapy
Locations1 site (St Louis, Missouri)
StatusRecruiting
StartedJuly 23, 2026
Main results expectedAugust 2, 2028
Study endsFebruary 2, 2030
Registry record updatedJuly 24, 2026
Trial IDNCT07392970 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with AML who achieved remission after 1–2 induction cycles and are scheduled for SOC MRD testing.

Probably not a fit

Patients with high-risk features or MRD dynamics not influenced by motixafortide may not see a benefit in MRD assessment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 pilot trial evaluating motixafortide given as a single injection to adults with AML who have achieved remission by standard criteria. Patients will have their usual MRD assessments performed, then receive motixafortide, and 10–14 hours later will have follow-up MRD testing on blood samples using the same assays. The goal is to see if motixafortide affects MRD determination, potentially refining risk stratification and guiding further therapy. Eligibility includes adults with AML (excluding APL), 1–2 induction cycles, adequate organ function, and planned SOC MRD testing. Primary outcomes focus on MRD measurement changes and safety in this context.

Why it matters

Potential benefit: If successful, this approach could improve the precision of MRD testing, helping tailor subsequent AML treatment decisions.

How similar studies have gone: MRD-directed endpoints have been explored in AML, but this specific MRD sensitization approach with motixafortide is novel or not yet established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosed with acute myeloid leukemia (AML), excluding APL, treated with 1-2 cycles of front-line chemotherapy.
* Achieved CBC parameters compatible with complete remission as defined by ELN 2022.
* Planning to undergo a standard of care blood draw and bone marrow assessment with SOC MRD assays, including morphology, flow cytometry for MRD, NGS panels for MRD, and PCR tests for MRD as applicable.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Life expectancy \> 3 months.
* Adequate organ function as defined below:

  * Total bilirubin ≤ 2.0 x IULN
  * AST(SGOT)/ALT(SGPT) ≤ 5.0 x IULN
  * Creatinine clearance \> 30 mL/min by Cockcroft-Gault
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Evidence of more than 5% blasts in in the peripheral blood by manual differential within 5 days prior to study enrollment.
* Prior history of allogeneic stem cell transplant.
* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to motixafortide.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.

Where it's running

  • Washington University School of Medicine
    St Louis, Missouri, United States     Recruiting

Study contacts

  • Principal investigator: Samuel Urrutia, MD — Washington University School of Medicine
  • Study coordinator: Samuel Urrutia, MD
  • Email: surrutia@wustl.edu
  • Phone: 314-273-6734

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.