Phase 2 Leukaemia Trial, Recruiting

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

Who might be able to join this trial:

• Children who were first diagnosed between 1 year old (at least 12 months) and 18 years old, and who are younger than 21 years old at the time of joining the trial.
• Children under 6 years old who weigh at least 7 kg, and children 6 years or older who weigh at least 10 kg at the time of joining.
• Children who are well enough to carry out at least some daily activities, as measured by a standard health scoring tool appropriate for their age (confirm with trial site).
• Families or legal guardians who are willing and able to provide written consent, and patients who are able to give age-appropriate agreement to participate, before any trial screening begins.
• Patients whose cancer has been tested using molecular profiling and cell analysis before joining the trial; this testing must have been done on the cancer at the time it came back or stopped responding to treatment.
• Patients whose cancer has a specific type of genetic change (called a RAS pathway activating mutation) identified through molecular testing — this includes changes in genes such as KRAS, NRAS, HRAS, FLT3, PTPN11, MAP2K1, NF1, and others.
• Patients whose kidneys are working well enough, based on blood tests done within 48 hours before starting treatment (confirm with trial site).
• Patients whose liver is working well enough, based on blood tests done within 48 hours before starting treatment — patients with liver problems caused by the disease itself may still be considered after discussion with the trial team.
• Patients whose heart is functioning adequately, as confirmed by a heart scan (echocardiogram or similar), and who do not have a specific type of irregular heart rhythm or abnormal heart electrical reading.

Who may not be able to join:

• People who are pregnant, or who test positive for pregnancy within 7 days before starting treatment.
• Sexually active participants who are not willing to use a highly effective form of contraception during the trial and for 6 months after the end of treatment.
• People who are currently breastfeeding.
• Patients who have stomach or bowel conditions that could significantly affect how oral medications are absorbed by the body (such as severe nausea, vomiting, diarrhoea, or malabsorption).
• Patients who have had a known serious allergic or sensitivity reaction to any of the study drugs, related drugs, or their ingredients — including certain standard chemotherapy drugs and steroids.
• Patients with a known active hepatitis virus infection, HIV infection, or any other infection that is not under control.
• Patients with a serious other illness that, in the treating doctor's judgement, would prevent safe participation in the trial.
• Patients or families who are unwilling or unable to follow the trial procedures.
• Patients who have previously been treated with a drug called trametinib.
• Patients currently taking certain medications or herbal supplements that are not permitted during the trial, including medications known to affect heart rhythm in a specific way (confirm with trial site for the full list).
• Patients who still have significant side effects (grade 2 or higher on a standard medical scale) from previous cancer treatment or surgery, unless the trial doctors consider these to be not clinically meaningful given the treatment being studied.
• Patients with active graft-versus-host disease (a complication that can occur after a bone marrow transplant) of any severity, or a chronic form rated grade 2 or above; patients currently taking medication to treat or prevent this condition after a bone marrow transplant are not eligible.
• Patients who have received immune-suppressing medication after an allogeneic stem cell transplant within one month of joining the trial.
• Patients with a current or past history of certain eye conditions affecting the retina (retinal vein occlusion or central serous retinopathy).
• Patients who have not waited long enough since their last cancer treatment — specific waiting periods apply depending on the type of treatment received (chemotherapy, radiotherapy, stem cell transplant, immunotherapy, antibody therapy, investigational drugs, or major surgery), and these vary from 48 hours to 3 months depending on the treatment type (confirm exact timeframes with trial site).

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