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 (May 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
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)
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 →
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