RecruitingAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemia
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
Eligible age
12+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Meryx, Inc.
You may qualify if…
- ✓ Patient is a male or female at least 12 years of age.
- ✓ Patient must weigh at least 40 Kg.
- ✓ Patient has histologically or cytologically confirmed diagnosis of AML as defined by the World Health Organization (WHO) criteria (2017), ALL, or MPAL and is in second or later relapse or is refractory to at least one induction regimen.
- ✓ The effects of MRX-2843 on developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to remain abstinent, or agree to practice double barrier forms of birth control in which 2 of the following precautions are used during the study and for 4 months after last dose of study drug(s): vasectomy, tubal ligation (or other transcervical sterilization procedures), vaginal diaphragm, intrauterine device, birth control pills, birth control implant, or condom or sponge with spermicide.
- ✓ Female patients of childbearing potential must be nonpregnant, nonlactating, and have a negative pregnancy test result at Screening and a negative pregnancy test on Day 1 of Cycles 1-4.
- ✓ Patient is able to provide written, informed consent or assent for patients \< 18 years of age is provided along with parent/guardian consent before initiation of any study related procedures, and patient is able, in the opinion of the investigator, to comply with all the requirements of the study.
- ✓ Patient is able to swallow oral medication.
- ✓ Patient has white blood cell (WBC) lower than 25,000/mm3 at Screening prior to initiation of MRX-2843. Patients who are otherwise medically eligible for enrollment but have WBC above 25,000/mm3 are allowed concurrent treatment with hydroxyurea to stabilize the WBC. In these situations, hydroxyurea will be discontinued once WBC is below 10,000/mm3 and at least 1 day prior to start of study treatment. Treatment with hydroxyurea will be allowed during Cycle 1 if deemed needed by the Investigator.
You may not qualify if…
- ✕ To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer:
- ✕ All Subjects:
- ✕ Patient has diagnosis of acute promyelocytic leukemia (or AML M3).
- ✕ Patients with known active CNS leukemia.
- ✕ Patient has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the patient at risk.
- ✕ Patient has a history of other malignancies that have required systemic treatment within the last 2 years or are deemed by the investigator to have a potential to interfere with the safety and efficacy assessment of MRX2843. Patients with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
- ✕ Patient has received radionuclide treatment within 6 weeks of the first dose of study treatment.
- ✕ Patient has received systemic antineoplastic therapy within 14 days of study treatment or 6 weeks for nitrosoureas or mitomycin C. (However, hydroxyurea can be given for the purposes of cytoreduction up to 1 day prior to enrollment, with the exceptions noted above in the inclusion criteria).
Where it's recruiting
Source: ClinicalTrials.gov · NCT04872478 · last updated 2026-01-08