Trametinib plus azacitidine for newly diagnosed JMML
Treatments studied
Part of Blood & lymphatic, Brain & nervous system, Cancer, Genetic & congenital clinical trials.
This trial studies whether trametinib and azacitidine can control juvenile myelomonocytic leukemia (JMML) soon after diagnosis. It’s designed to test safety and how well the treatment works in children and young adults who meet specific leukemia and genetic criteria.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are between 1 month and 21 years old at the time of enrollment.
- Your diagnosis fits the 2022 JMML criteria, including certain blood test and spleen findings and no BCR::ABL1 gene change.
- Your JMML has at least one specific genetic feature (for example PTPN11, KRAS, NRAS, RRAS, or CBL related changes; or NF1-related findings).
- You have not had leukemia-directed treatment before, except brief “cancer-reducing” medicines allowed shortly before starting (like hydroxyurea or 6-MP) and certain spinal fluid chemo for diagnosis.
- You do not have serious heart, liver, or kidney problems that fail the study limits, and you can meet the study’s heart testing (ejection fraction).
- You cannot have certain exclusions such as prior stem cell transplant, MEK inhibitor use, known drug allergy, or active infections that are not improving; and you must not have Noonan syndrome or Down syndrome.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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