Phase 1 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 and young people aged 1 to 18 years old at the time of joining the study.
• People with acute myeloid leukemia (AML), treatment-related AML, myelodysplastic syndrome (MDS), or a rare blood cancer called JMML (juvenile myelomonocytic leukemia), with or without Down syndrome.
• People with AML whose cancer has come back for a second time or more, or whose cancer has not responded to treatment, including disease that has spread outside the bone marrow — but not cases where the cancer has only returned in the brain/spinal fluid or only in the testicles.
• People with MDS whose cancer has come back at least once after treatment.
• People with JMML whose cancer has come back at least once after treatment, and who have already received at least one cycle of intensive treatment or at least two cycles of a specific type of medication.
• People whose blood cancer has been confirmed through specific laboratory tests showing a certain level of cancer cells in the bone marrow or blood (confirm with trial site for exact thresholds and testing requirements).
• People who have no other known treatment available that could cure their disease or meaningfully extend their life with an acceptable quality of life.
• People who are well enough to carry out some daily activities, based on standard medical scoring scales (a score of at least 50 on the relevant scale for their age).
• People whose side effects from any previous cancer treatment have mostly resolved before joining the trial, and who have waited the required amount of time since their last treatment (the exact waiting period depends on the type of treatment previously received — confirm with trial site).
• People who have never previously received the study drug imetelstat.
• People with a platelet count of at least 25,000 per microlitre (transfusions are allowed to reach this level, provided the person is not known to be unresponsive to transfusions).
• People with a haemoglobin level of at least 8.0 g/dL (transfusions are allowed to reach this level).
• People whose kidneys are working well enough, based on a kidney function test result of at least 70 mL/min/1.73 m².
• People whose liver is working well enough, based on blood test results within acceptable ranges for bilirubin, liver enzymes (ALT and AST), and albumin levels.
• People whose heart is working well enough, shown by an echocardiogram result of at least 27% shortening fraction, or at least 50% ejection fraction on a heart scan.

Who may not be able to join:

• People who are pregnant or breastfeeding, or those who are able to have children and are unwilling to use two effective methods of contraception during the study and for the required time after the last dose of treatment.
• People currently taking corticosteroid medications (such as prednisone) whose dose has not been stable or decreasing for at least 7 days before joining, unless it is a low physiological dose; or people who took corticosteroids to manage side effects from prior treatment within the last 14 days.
• People who are currently taking part in another clinical trial involving an experimental drug.
• People who are currently receiving other cancer treatments, except hydroxyurea (which must be stopped at least 24 hours before starting trial treatment).
• People who are taking medications to prevent graft-versus-host disease after a bone marrow transplant, such as cyclosporine or tacrolimus.
• People with a mild, low-grade form of MDS (called refractory cytopenia of childhood) that has less than 2% cancer cells in the blood or less than 5% in the bone marrow.
• People with a seizure disorder that is not well controlled with medication.
• People who have had surgery requiring general anaesthesia within 3 weeks before joining (minor procedures such as line placement are generally allowed — confirm with trial site).
• People with a known allergy to the study drug imetelstat or any of its ingredients.
• People with a specific subtype of AML called acute promyelocytic leukemia (APL) with a particular genetic change (PML-RARA or t(15;17)).
• People with certain inherited bone marrow failure conditions — for example, dyskeratosis congenita — where the risk of serious side effects may be higher.
• People whose cancer has only returned in the brain/spinal fluid or only in the testicles, and has not responded to treatment.
• People with an infection that is not currently under control.
• People who have previously received a solid organ transplant (such as a kidney or liver transplant).
• People who, in the opinion of the treating doctor, may not be able to safely follow the monitoring and safety requirements of the study.

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