RecruitingPhase 1NCT04872478

Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL

An Open Label Evaluation Phase 1 Trial of the Safety and Pharmacokinetics of MRX-2843 in Adolescents and Adults With Relapsed/Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Mixed Phenotype Acute Leukemia


Sponsor

Meryx, Inc.

Enrollment

50 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests how the body processes a new drug called MRX-2843 in teenagers and adults with acute leukemia (AML, ALL, or mixed-type leukemia) that has relapsed or not responded to at least one round of chemotherapy. Researchers also want to understand its safety profile in this younger population. **You may be eligible if...** - You are at least 12 years old and weigh at least 40 kg - You have been diagnosed with AML, ALL, or mixed-phenotype acute leukemia that has relapsed at least twice or has not responded to at least one chemotherapy regimen - You are able to swallow oral medication - You have white blood cell counts below 25,000/mm3 at screening - If female, you are not pregnant or breastfeeding and agree to use contraception **You may NOT be eligible if...** - Your leukemia has never been treated before - You have only relapsed once and that relapse responded to treatment - You cannot swallow pills - You are pregnant or breastfeeding - You have significant organ problems affecting eligibility Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMRX-2843

MRX-2843 capsules


Locations(3)

Emory University - WINSHIP Cancer Center

Atlanta, Georgia, United States

Emory University, Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT04872478


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