Phase 2 Leukaemia Trial, Recruiting NCT05503134 Sponsor: Nationwide Children's Hospital Condition: Leukaemia
Back to Leukaemia

Phase 2 Leukaemia Trial, Recruiting

NCT05503134
Recruiting Phase 2

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 2
Sponsor
Nationwide Children's Hospital
Registry
ClinicalTrials.gov
Start date
14 February 2022
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence and severity of adverse events; Rate of dose limiting toxicities

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov