Phase 2 Leukaemia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People diagnosed with acute myeloid leukaemia (AML) that has come back after treatment, or AML that did not respond to at least two rounds of standard chemotherapy (including cases where the disease is still detectable at a very low level)
- People whose AML is found only in the brain/spinal fluid or in areas outside the bone marrow may also be considered (confirm with trial site)
- People aged between 1 and 24 years old (up to but not including 25)
- Females who could become pregnant must have a negative pregnancy test within 2 weeks before joining the trial
- Sexually active participants who could cause or become pregnant must agree to use an effective form of contraception (as decided by the doctor) for 6 months after the last dose of treatment
- People who have tested negative for HIV
- People of any gender, race, or ethnic background are welcome to apply
- People whose kidneys are working well enough to meet specific measurements (confirm with trial site for exact values)
- People whose liver is working well enough to meet specific measurements (confirm with trial site for exact values)
- People whose heart is pumping well enough to meet specific measurements, or who have been cleared by a heart specialist
- People with a history of seizures may be considered if their seizures are well controlled
- People whose side effects from previous treatments have mostly cleared up before joining
- All participants, and/or their parent or legal guardian, must be willing and able to sign a consent form
Who may not be able to join:
- People who have received AML treatments within 2 weeks before starting this trial (a common medication called hydroxyurea is an exception; certain medications given directly into the spinal fluid are also exceptions)
- People currently taking medications that suppress the immune system, or who have been on such medications within the 2 weeks before joining, or who show signs of a complication called graft-versus-host disease (GVHD)
- People who have received a type of treatment called donor lymphocyte infusion or other cell-based therapy within the last 30 days
- People who have had a stem cell transplant from a donor less than 3 months before joining
- People with other serious health conditions that the trial doctor believes would make it unsafe to receive the study treatment
- People whose general health and ability to perform daily activities falls below a certain level on a standard medical scale (confirm with trial site for exact threshold)
- People with an active infection that has not shown clear signs of improving with treatment (note: certain viruses in the blood that cause no symptoms, such as CMV or HCV, are not considered a reason to exclude someone)
- People with heart rhythm problems that are not controlled, or heart symptoms that are not controlled
- People with a history of autoimmune disease (a condition where the immune system attacks the body)
- People who currently have active graft-versus-host disease (GVHD) at the time of joining
- People who have previously received a type of immune cell treatment called adoptive cell therapy, unless it has been at least 30 days since that treatment and blood counts have recovered to a certain level (confirm with trial site for exact values)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Margaret Lamb, MD, Nationwide Children's Hospital
Phone: 6147226039
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Incidence and severity of adverse events; Rate of dose limiting toxicities
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.