Phase 3 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:

• People who have already been enrolled in a related screening study called APEC14B1 and have completed the eligibility screening step before joining this trial
• People who are under 22 years of age at the time of joining the study
• People who have been newly and freshly diagnosed with AML (a type of blood cancer) according to 2016 medical classification standards, with or without the cancer having spread to areas outside the bone marrow
• People whose bone marrow test (taken within 14 days before joining) shows 20% or more abnormal cancer cells (blasts), OR people with less than 20% blasts but with certain specific genetic changes linked to AML in children and young adults, OR people whose blood test (taken within 7 days before joining) shows a high enough number of circulating cancer cells if a bone marrow test cannot be performed
• For Arm C only: People who are at least 2 years old at the time of a specific later assessment point in the study
• For Arm C only: People whose cancer has a specific gene change called FLT3/ITD with an allelic ratio above 0.1, as confirmed by a specialist laboratory
• For Arm C only: People who do not have a condition called congenital long QT syndrome or congenital heart block (a heart rhythm condition present from birth)
• For Arm C only: Women who are able to become pregnant and agree to use effective birth control during treatment and for at least 6 months after the last dose of a study drug called gilteritinib
• For Arm C only: Women who are currently breastfeeding and agree to stop breastfeeding during treatment and for 2 months after the last dose of gilteritinib
• For Arm C only: Men who are able to father children and agree to use effective birth control during treatment and for at least 4 months after the last dose of gilteritinib
• For Arm D only: People who are at least 2 years old at the time of a specific later assessment point in the study
• For Arm D only: People whose cancer has a specific type of gene change in the FLT3 gene (a non-ITD activating mutation), as confirmed by a specialist laboratory
• For Arm D only: Women who are able to become pregnant and agree to use effective birth control during treatment and for at least 6 months after the last dose of gilteritinib
• For Arm D only: Women who are currently breastfeeding and agree to stop breastfeeding during treatment and for 2 months after the last dose of gilteritinib
• For Arm D only: Men who are able to father children and agree to use effective birth control during treatment and for at least 4 months after the last dose of gilteritinib
• For the optional brain and thinking skills testing only: People enrolled in Arm A or Arm B (not Arm C or Arm D), who are 5 years of age or older, and who speak English, French, or Spanish
• For the optional brain and thinking skills testing only: People with no known history of a developmental condition affecting learning or thinking (such as Down syndrome, Fragile X syndrome, Williams syndrome, or intellectual disability) before their AML diagnosis, and no significant vision or movement difficulties that would prevent use of a computer or recognition of visual images
• All participants, and/or their parents or legal guardians, must sign a written consent form agreeing to take part
• All relevant institutional, government, and cancer research requirements for human studies must be met

Who may not be able to join:

• People with a genetic condition called Fanconi anemia
• People with a condition called Shwachman-Diamond syndrome
• People with Down syndrome (including mosaic forms, where only some cells are affected)
• People with telomere disorders (inherited conditions affecting the protective ends of chromosomes)
• People with an inherited tendency that the treating doctor believes could increase the risk of serious side effects from AML treatment
• People who currently have another type of cancer at the same time
• People diagnosed with a related blood condition called juvenile myelomonocytic leukemia (JMML)
• People whose AML involves a specific chromosome change called the Philadelphia chromosome
• People with a mixed type of acute leukemia that involves more than one type of blood cell
• People with a specific subtype of AML called acute promyelocytic leukemia
• People whose AML developed from a pre-existing bone marrow condition called myelodysplasia
• People with a blood cancer that developed as a result of previous cancer treatment
• People with ongoing, significant heart weakness before joining the trial, specifically where the heart is pumping less effectively than a defined threshold on an ultrasound scan (confirm specific values with the trial site) — though a repeat heart scan may be considered after the person has stabilised, and a normal result could allow participation
• People who have already received cancer treatment, with the exception of certain limited medications (including hydroxyurea, a drug called ATRA, steroid medications by any method, or chemotherapy given directly into the spinal fluid at the time of diagnosis)
• People whose current medications include strong interacting drugs that could interfere with how gilteritinib works in the body, particularly if gilteritinib may be part of their treatment (confirm with trial site)
• People who are currently pregnant
• Women who are breastfeeding and plan to continue breastfeeding during the study
• People who are sexually active and able to have children but have not agreed to use an effective method of contraception throughout the study
• For Arm D only: People who have congenital long QT syndrome or congenital heart block (heart rhythm conditions present from birth)

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