OncoMatch/Clinical Trials/NCT04872478
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
Is NCT04872478 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies MRX-2843 for acute myeloid leukemia.
Treatment: MRX-2843 — This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Allowed: FLT3 ITD
For the FLT3ITD expansion cohort at RP2D, the FLT3ITD+ patients should have previously been treated with at least one FLT3 inhibitor prior to enrollment.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: induction regimen
is in second or later relapse or is refractory to at least one induction regimen
Cannot have received: radionuclide treatment
Patient has received radionuclide treatment within 6 weeks of the first dose of study treatment.
Cannot have received: systemic antineoplastic therapy
Exception: hydroxyurea can be given for the purposes of cytoreduction up to 1 day prior to enrollment
Patient has received systemic antineoplastic therapy within 14 days of study treatment or 6 weeks for nitrosoureas or mitomycin C.
Cannot have received: calcineurin inhibitor
Patient has received calcineurin inhibitors within four weeks of study treatment.
Cannot have received: small molecular kinase inhibitor or any investigational drug or product
Patient has used a small molecular kinase inhibitor or any investigational drug or product within 28 days or 5 half lives, whichever is longer, before study drug dosing.
Lab requirements
Blood counts
WBC lower than 25,000/mm3 at Screening prior to initiation of MRX-2843. Hydroxyurea allowed for cytoreduction.
Kidney function
Creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft and Gault equation)
Liver function
Bilirubin ≤ 1.5 the upper limit of normal (ULN). For patients with documented Gilbert's disease, bilirubin ≤ 3.0 mg/dL. ALT and AST ≤ 3.0 × ULN
Cardiac function
QTcF ≤ 480 ms. Congestive heart failure NYHA class 3 or 4 excluded unless LVEF ≥ 45% by echo within 3 months prior to entry.
Patient has laboratory values at Screening: Bilirubin ≤ 1.5 ULN (≤ 3.0 mg/dL for Gilbert's), CrCl ≥ 60 mL/min, ALT/AST ≤ 3.0 × ULN. QTcF ≤ 480 ms. Congestive heart failure NYHA class 3 or 4 excluded unless LVEF ≥ 45%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University - WINSHIP Cancer Center · Atlanta, Georgia
- Emory University, Children's Healthcare of Atlanta · Atlanta, Georgia
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04872478 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radionuclide treatment, systemic antineoplastic therapy, calcineurin inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify