Motixafortide for MRD Sensitization in AML (NCT07392970) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Motixafortide for MRD Sensitization in AML
United States10 participantsStarted 2026-05-31
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. This must be done within 5 days prior to study enrollment.
* 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. Legally authorized representatives may sign and give informed consent on behalf of study participants.
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 a…
What they're measuring
1
Efficacy of motixafortide on measurable residual disease (MRD) levels
Timeframe: Day 1 before motixafortide and Day 2 (estimated total time is 2 days)