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Motixafortide for MRD Sensitization in AML
NCT07392970Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Aug 2028
- Countries
- 1
- Sponsor
- Washington University School of Medicine
- Modality
- Peptides
- Drugs
- motixafortide
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of motixafortide in acute myeloid leukemia (AML), sponsored by Washington University School of Medicine. Primary endpoint: Efficacy of motixafortide on measurable residual disease (MRD) levels at Day 2. Started Jul 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Motixafortide Injection
Single injection of Motixafortide followed by MRD testing
03
Who it enrols
Adults with acute myeloid leukemia (AML) in complete remission after 1-2 cycles of front-line chemotherapy, with adequate organ function and ECOG performance status <= 2.
04
Endpoints
Primary
Efficacy of motixafortide on measurable residual disease (MRD) levels
Secondary
Proportion of patients changing from negative to positive MRD levels
Percentage change in variant allele frequency (VAF) levels by next-generation sequencing (NGS) using error-corrected sequencing (MRD-Seq)
Percentage change in VAF levels by NGS using MRD-Seq between bone marrow and peripheral blood assessments
Percentage change in detectable transcript levels by polymerase chain reaction (PCR)
Relapse-free survival
Time to next line of therapy
Overall survival
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