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Tests treatment safety and results for Acute Myeloid Leukemia
Official title Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
ClinicalTrials.gov ID: NCT04872478
What this study is testing
What is MRX-2843?
MRX-2843 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join 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...
- 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...
- Female patients of childbearing potential must be nonpregnant, nonlactating, and have a negative pregnancy test result at Screening and a negative...
You likely can't join if
- To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer: All people:
- 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...
- 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...
- Patient has received radionuclide treatment within 6 weeks of the first dose of study treatment.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- The Patient has laboratory values at Screening:
- Bilirubin ≤ 1.5 the upper limit of normal (ULN). For patients with documented Gilbert's disease, bilirubin ≤ 3.0 mg/dL
- Creatinine clearance (CrCl) ≥ 60 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72) (For females: Multiply...
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Lansky/Karnofsky ≥ 50.
- For the FLT3ITD expansion cohort at RP2D, the FLT3ITD+ patients should have previously been treated with at least one FLT3 inhibitor prior to enrollment.
What rules you out
- To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer: All people:
- 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...
- 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 how well it works...
- 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...
- Patient has not fully recovered from acute toxic effects due to all prior therapies, except alopecia and other non-clinically significant AEs prior to enrollment.
- Patient has active clinically significant GvHD.
- Patient has received calcineurin inhibitors within four weeks of study treatment.
- Patient is known to have human immunodeficiency virus infection (HIV).
- 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.
- Patient has a diagnosis of active hepatitis B or C.
- Patient has an active uncontrolled infection.
- Patient has a history of Type 1 Diabetes (T1D) or is considered at high risk for T1D, where high risk is defined as
- Patient has 1 first-degree relative (FDR; defined as parents, offspring or siblings) with T1D AND A1C value \> 6.5% or
- Patient has 2+FDR with T1D
- Patient has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.
- Patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or FXa inhibitors, and antiplatelet agents (e.g., clopidogrel). Low dose aspirin (≤...
- Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed...
- Patient has QTcF \> 480 ms.
- Patient has had major surgery within 4 weeks of the first dose of study drug.
- The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.