RecruitingPhase 2

Motixafortide for MRD Sensitization in AML

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small, early-stage study tests how motixafortide affects tests that measure tiny amounts of cancer left after treatment. It is for adults with acute myeloid leukemia (AML), a blood cancer, who have finished their first chemotherapy treatment. Patients get one injection after routine blood and bone marrow tests, then have another blood draw 10 to 14 hours later.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have AML, but not the type called APL, and have had 1 or 2 rounds of first-line chemotherapy.
  • Have blood cell counts that meet the study's standards for complete remission.
  • Plan to have routine blood and bone marrow tests to check for cancer cells left after treatment.
  • Can care for yourself and are out of bed or a chair for at least half of waking hours.
  • Are expected to live more than 3 months.
  • Have liver and kidney test results within the study's required limits.
  • Can understand the study and are willing to sign a consent form.

Who can't join

  • Have more than 5% blasts, or immature blood cells, in a blood test within 5 days before joining.
  • Have had a stem cell transplant from a donor.
  • Have another past or current cancer that could affect how the study's safety or results are judged.
  • Are taking another experimental drug, or have had an allergic reaction to a drug similar to motixafortide.
  • Have an uncontrolled illness, such as an active infection or certain heart problems. People with heart risks must meet the study's heart function standards.
  • Are pregnant or breastfeeding. Those who could become pregnant must have a negative pregnancy test within 14 days before joining.
  • Have HIV without effective treatment and virus levels too low to detect for at least 6 months.
  • Have chronic hepatitis B with virus still detected during treatment, or hepatitis C that has not been cured, unless current treatment has made the virus too low to detect.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MO

  • Washington University School of Medicine · St Louis, MO 63110Samuel Urrutia, MD · Study contact · 314-273-6734 · surrutia@wustl.eduSamuel Urrutia, MD · Principal investigatorJohn F DiPersio, MD, PhD · Sub-investigatorFeng Gao, MD, PhD, MPH · Sub-investigatorMore trials in St Louis