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:

• People enrolled in a related study called INITIALL.
• Children and adolescents who were between 1 and 18 years old at the time of joining INITIALL.
• People diagnosed with B-cell acute lymphoblastic leukemia (a type of blood cancer) or lymphoblastic lymphoma (a related cancer of the lymph system).
• People who have not had prior chemotherapy, other than treatment given as part of or permitted by the INITIALL study.
• People whose cancer is classified as high-risk — either because the patient is aged 10 or older, or because their white blood cell count at diagnosis was very high (50,000 cells/microL or more) — or people whose cancer is standard-risk but with at least one of these additional high-risk features:
  • The cancer has spread to the fluid around the brain and spinal cord (called CNS3 disease)
  • The cancer has affected the testicles
  • Steroid medicines were given for more than 24 hours in the 14 days before joining INITIALL, and an early white blood cell count to assess risk level was not available
• For lymphoblastic lymphoma specifically: people with Stage 3 or 4 disease, or Stage 1–2 disease in patients aged 10 or older, or those with one of the high-risk features listed above.
• People whose liver is working well enough, based on blood test results within acceptable ranges for their age (confirm with trial site for exact values).
• People whose kidneys are working well enough, based on kidney function test results appropriate for their age and sex (confirm with trial site for exact values).
• People joining after the initial treatment phase (called induction) must meet the first four criteria above and also at least one of the following:
  • They were treated on a specific related study called SJALL23H during induction, OR
  • They have lymphoblastic lymphoma, were treated on an SJALL study or standard therapy, and did not achieve a complete response by the end of induction, OR
  • They were initially standard-risk and treated on an SJALL study or standard therapy, but showed either a slow response to treatment (based on a lab test called MRD at the end of induction) or certain high-risk genetic features identified in the protocol (confirm with trial site for details) — and have received no more than 2 weeks of post-induction therapy before joining this study.

Who may not be able to join:

• People whose cancer has a specific genetic change called ETV6::RUNX1 fusion, unless they also have a high-risk clinical feature or showed a slow response to induction treatment.
• People with a significant history of, or current, serious brain or nervous system conditions — such as epilepsy, non-fever-related seizures, stroke, severe brain injury, dementia, or psychosis. Note: a history of simple febrile (fever-related) seizures in childhood or leukemia affecting the brain fluid at diagnosis does not exclude someone (confirm with trial site).
• People with an active, uncontrolled infection at the time of enrolment.
• People with a currently active autoimmune disease, or a history of an autoimmune disease that could affect the brain or nervous system.
• People with a history of a serious liver condition called veno-occlusive disease or sinusoidal obstructive syndrome.
• People with unstable heart disease, including an abnormal heart rhythm measurement (QTc greater than 500msec) on testing.
• People who are unable or unwilling to provide informed consent (or assent, where applicable by age).
• People who are pregnant or breastfeeding.
• People who are capable of reproduction but are unwilling to use effective contraception for the full duration of the study treatment.

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