Motixafortide for MRD Sensitization in AML

This study is looking at how a drug called Motixafortide affects the levels of measurable residual disease (MRD) in people with acute myeloid leukemia (AML). MRD refers to a small number of cancer cells that can remain in the body after treatment. You might be able to join if you have AML (excluding a specific type called APL), have completed 1-2 cycles of initial chemotherapy, and your blood counts show you are in complete remission. The study will measure your MRD levels before and after you receive a single injection of Motixafortide. Researchers want to see if Motixafortide can change these MRD levels. This is a small, early-stage study aiming to enroll 10 participants.

Study design: This is a small, early-stage study (pilot phase I) involving 10 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved: You will undergo standard bone marrow and blood tests for MRD, receive a single injection of Motixafortide, and then have another blood collection 10-14 hours later for the same MRD tests.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint for efficacy is measured at Day 1 before Motixafortide and Day 2, suggesting a very short follow-up period of about 2 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Motixafortide for MRD Sensitization in AML

Recruiting

PHASE2Ages 18+InterventionalDiagnostic

Washington University School of Medicine

~10 participants

Updated 2026-07-24 on ClinicalTrials.gov

What's tested:Motixafortide

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Efficacy of motixafortide on measurable residual disease (MRD) levels

Measured over Day 1 before motixafortide and Day 2 (estimated total time is 2 days)

Conditions

Acute Myeloid Leukemia

Measurable Residual Disease

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Samuel Urrutia, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Samuel Urrutia, MD

[email protected]

314-273-6734

Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Efficacy of motixafortide on measurable residual disease (MRD) levelsDay 1 before motixafortide and Day 2 (estimated total time is 2 days)
The efficacy of motixafortide on MRD levels will be measured as the proportion of patients who have at least one of the following, as measured in peripheral blood, before versus after motixafortide: MRD negative to MRD positive conversion, or the 5% absolute increase in MRD level by flow cytometry, or leukemia defining polymerase-chain reaction (PCR) transcript (For fusion-driven leukemias or NPM1 and FLT3-ITD-mutated leukemias) or 5% increase in the VAF of recurrent leukemia associated gene mutations by next-generation sequencing (NGS).

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