Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 1 month old and no older than 21 years of age at the time of joining.
• People who have been diagnosed with Juvenile Myelomonocytic Leukemia (JMML) according to the 2022 International Consensus Classification criteria, which involves specific blood test results, an enlarged spleen, and certain genetic findings.
• People whose general health and ability to function meets a minimum level, measured by age-appropriate medical scales (confirm with trial site).
• People who have not previously received treatment aimed at the leukemia, with limited exceptions: short-term use of certain medicines to reduce blood cell counts (hydroxyurea for up to 24 hours, or 6-mercaptopurine for up to 72 hours before starting the trial drug), or certain injections into the spinal fluid given within 7 days of joining as part of diagnosis.
• People whose kidneys are working well enough, based on blood or urine tests appropriate for their age and sex.
• People whose liver is working well enough, based on blood test results — though this requirement may be waived if the leukemia is affecting the liver (requires approval from the study chair).
• People whose heart is pumping well enough, with the heart pumping at least 50% of its capacity as measured by a heart scan.
• Female patients who could become pregnant must have a negative pregnancy test within 2 weeks before joining.
• Female patients who are breastfeeding must agree not to breastfeed while on the study.
• People who could become pregnant or father a child must agree to use an effective form of contraception during the study and for at least 6 months after treatment ends.

Who may not be able to join:

• People who have a known allergy to any of the medicines used in the study.
• People who have an active fungal, bacterial, viral, or other infection that is not improving with appropriate treatment, or who still need blood pressure support medications, or who have had positive blood cultures in the past 48 hours.
• People who are planned to receive chemotherapy, radiation therapy, or immunotherapy outside of this study's protocol during the study period.
• People who have a serious other illness, psychiatric condition, or personal situation that could affect their safety, their ability to follow the study plan, or the reliability of the study results.
• People who have a diagnosis of Noonan syndrome (note: people with neurofibromatosis type 1 or CBL syndrome may still be eligible — confirm with trial site).
• People who have Down syndrome.
• People who have previously received growth factor medications, biological anti-cancer treatments, or radiation therapy.
• People who are currently taking medications to treat reduced heart pumping function.
• People who have a current or previous history of certain eye conditions affecting blood vessels in the retina (confirm with trial site).
• People who have previously taken any medication belonging to the class known as MEK inhibitors.

Important: Always verify eligibility with the trial site directly before applying.