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:

• People who have given written consent to participate (or whose legal representative has done so on their behalf)
• People aged 60 or older, OR people aged 18–59 who have a HCT-Comorbidity Index score of 2 or higher (a measure of overall health and existing conditions — confirm with trial site)
• People with a performance status score of 70 or higher on the Karnofsky scale, meaning they are able to carry out normal activity with some effort
• People with a confirmed diagnosis of one of the following blood cancers:
  • Acute myeloid leukaemia (AML): either newly diagnosed or secondary disease with high-risk features, OR leukaemia that has responded to treatment (in remission) but where low levels of cancer cells can still be detected on testing, OR active disease that has reduced by at least 50% after the most recent treatment
  • Myelodysplastic syndrome (MDS): classified as intermediate-2 or high risk based on a standard scoring system called the IPSS-R
  • Acute lymphocytic leukaemia (ALL): either newly diagnosed or secondary disease with certain high-risk features, OR disease in remission but with low levels of cancer cells still detectable on testing, OR active disease that has reduced by at least 50% after the most recent treatment
• People whose kidneys are working well enough, based on a blood test result showing a creatinine clearance of at least 60 ml/minute (tested within 30 days before starting treatment)
• People with liver function results within acceptable ranges, based on blood tests for bilirubin, SGOT, and SGPT (tested within 30 days before starting treatment)
• People whose heart is pumping at 50% efficiency or better, measured by an echocardiogram or MUGA scan (tested within 30 days before starting treatment)
• People whose lungs are functioning above 50% of the expected level on two specific breathing tests called DLCO and FEV1 (tested within 30 days before starting treatment)
• People of childbearing potential who agree to use effective contraception or abstain from sexual activity during the study and for at least 6 months after the last dose of treatment
• People who have a suitable stem cell donor — either a brother or sister who is a full tissue-type (HLA) match, or an unrelated donor who matches on 10 out of 10 tissue-type markers; the donor must also meet standard screening requirements including for COVID-19

Who may not be able to join:

• People who have previously had an allogeneic (donor) stem cell transplant
• People who have previously received radiation therapy
• People who have previously received radiopharmaceutical therapy (a type of treatment using radioactive substances)
• People with leukaemia or MDS who have already received more than 3 prior treatment courses intended to achieve remission
• People who have received another experimental treatment, or intensive chemotherapy or radiation therapy, within the 2 weeks before the conditioning phase of this trial
• People who have not stopped prior intensive chemotherapy or radiation therapy at least 2 weeks before starting the trial (note: certain low-dose or maintenance medications may be allowed closer to the start date — confirm with trial site)
• People with a known allergy or allergic reaction to substances similar to the study treatment
• People who currently have another active cancer, other than certain non-melanoma skin cancers
• People with an uncontrolled illness, including an active bacterial, viral, or fungal infection
• People with a medical, neurological, or psychiatric condition that, in the treating doctor's judgement, would make it unsafe for them to undergo transplantation or prevent them from following the treatment plan
• Women who are pregnant or breastfeeding
• People who, in the investigator's judgement, have any other condition that would make participation unsafe
• People who, in the investigator's judgement, may not be able to follow all study procedures and requirements

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