Actively Recruiting
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
Led by Meryx, Inc. · Updated on 2026-01-08
50
Participants Needed
3
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 12 years or older
- Weight of at least 40 kg
- Histologically or cytologically confirmed diagnosis of AML, ALL, or MPAL in second or later relapse or refractory to at least one induction regimen
- Agreement to use double barrier birth control or abstinence during the study and for 4 months after last dose (for women of childbearing potential and men)
- Female patients of childbearing potential must be nonpregnant, nonlactating, with negative pregnancy tests at screening and on Day 1 of Cycles 1-4
- Ability to provide written informed consent or assent with parent/guardian consent if under 18 years
- Ability to swallow oral medication
- White blood cell count below 25,000/mm3 at screening; hydroxyurea allowed to stabilize WBC if needed
- Laboratory values at screening: bilirubin ≤1.5 times upper limit of normal (≤3.0 mg/dL if Gilbert's disease), creatinine clearance ≥60 mL/min, ALT and AST ≤3 times upper limit of normal
- ECOG performance status 0-2 or Lansky/Karnofsky ≥50
- For FLT3ITD expansion cohort, prior treatment with at least one FLT3 inhibitor
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (AML M3)
- Known active central nervous system leukemia
- Any surgical or medical condition interfering with drug absorption, metabolism, or safety
- History of other malignancies requiring systemic treatment within last 2 years, except treated nonmelanoma skin cancer or certain in situ carcinomas
- Radionuclide treatment within 6 weeks before first dose
- Systemic antineoplastic therapy within 14 days before study treatment (6 weeks for nitrosoureas or mitomycin C), except hydroxyurea up to 1 day prior
- Not fully recovered from acute toxic effects of prior therapies except alopecia and non-significant adverse events
- Active clinically significant graft-versus-host disease
- Received calcineurin inhibitors within 4 weeks before study treatment
- Known HIV infection
- Use of small molecular kinase inhibitors or investigational drugs within 28 days or 5 half-lives before dosing
- Active hepatitis B or C
- Active uncontrolled infection
- History of Type 1 Diabetes or high risk defined by family history and A1C levels
- Known or suspected retinitis pigmentosa or family history of it
- Requirement for therapeutic doses of certain anticoagulants or antiplatelet agents (some low doses permitted)
- Congestive heart failure NYHA class 3 or 4 or history of such unless left ventricular ejection fraction ≥45%
- QTcF interval >480 ms
- Major surgery within 4 weeks before first dose
- Unable or unwilling to comply with study protocol or cooperate fully with study staff
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Emory University - WINSHIP Cancer Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Emory University, Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
M
Meryx
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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