Recruiting
Phase 2

Motixafortide

Sponsor:

Washington University School of Medicine

Code:

NCT07392970

Conditions

Acute Myeloid Leukemia

Measurable Residual Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Motixafortide

Study Details

Brief 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. 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

Conditions

Acute Myeloid Leukemia

Measurable Residual Disease

Study ID

NCT07392970

Start date

Jul 23, 2026

Status verified date

Jul, 2026

Completion date

Feb 2, 2030

Anticipated

Primary completion date

Aug 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Motixafortide

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.

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 and Locations

Central contacts

Samuel Urrutia, MD

314-273-6734surrutia@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Samuel Urrutia, MD

314-273-6734surrutia@wustl.edu

Principal Investigator:

Samuel Urrutia, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • AML
  • MRD
  • NGS
  • PCR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-24.