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Acute Myeloid LeukemiaPhase 2NCT07392970

Motixafortide for MRD Sensitization in AML

A Phase 2 study testing Motixafortide in people with Acute Myeloid Leukemia and Measurable Residual Disease, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Motixafortide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
23 Jul 2026to 2 Feb 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Samuel Urrutia, MD contact

314-273-6734

surrutia@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Samuel Urrutia, MD, 314-273-6734, surrutia@wustl.edu

    Samuel Urrutia, MD

    Recruiting

Other trials in United States

About this study

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

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

Being tested
Motixafortide
Keywords
AML, MRD, NGS, PCR
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MotixafortideDrug

    Also called Aphexda

    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 groups in NCT07392970
Study groupRoleWhat they receive
Motixafortide InjectionExperimentalConsenting 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.
Receives: Drug: Motixafortide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of motixafortide on measurable residual disease (MRD) levels

    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).

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

Secondary outcomes (7)

  1. Proportion of patients changing from negative to positive MRD levels

    The proportion will be calculated by number of patients with negative MRD levels at enrollment who had positive MRD levels measured after treatment compared to total number of patients.

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

  2. Percentage change in variant allele frequency (VAF) levels by next-generation sequencing (NGS) using error-corrected sequencing (MRD-Seq)

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

  3. Percentage change in VAF levels by NGS using MRD-Seq between bone marrow and peripheral blood assessments

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

  4. Percentage change in detectable transcript levels by polymerase chain reaction (PCR)

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

  5. Relapse-free survival (RFS)

    RFS is defined as the duration of time from the date of MRD testing to disease relapse or death from any cause, whichever occurs first. Patients who are alive without disease relapses at the time of database lock for analysis will be censored at the last follow up date. Relapse is defined in the ELN 2022 criteria as bone marrow blasts ≥ 5% or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart or development of extramedullary disease.

    Measured: From Day 1 through completion of follow-up (estimated total time is 18 months)

  6. Time to next line of therapy

    Measured as the duration of time between initial MRD testing and next line of therapy.

    Measured: From Day 1 through completion of follow-up (estimated total time is 18 months)

  7. Overall survival (OS)

    OS is defined as the duration of time from the date of MRD testing to death from any cause. Patients who are alive at the time of database lock for analysis will be censored at the last follow up date.

    Measured: From Day 1 through completion of follow-up (estimated total time is 18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start23 Jul 2026
  3. Primary completion2 Aug 2028 (estimated)
  4. Study completion2 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07392970
Sponsor's protocol ID
202603045
Status last verified
Jul 2026
First submitted
29 Jan 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual, de-identified data that has been published will be available for other investigators with approval from the study's PI and Sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Motixafortide in people with Acute Myeloid Leukemia and Measurable Residual Disease, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Samuel Urrutia, MD (314-273-6734, surrutia@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07392970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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