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 aged 50 to 70 years old, or people aged 18 to 49 who their treating doctor considers unable to tolerate a full-strength bone marrow transplant preparation regimen, who are being considered for a stem cell transplant from a donor
• People diagnosed with one of the following blood cancers or related conditions: acute lymphocytic leukaemia (ALL), acute myeloid leukaemia (AML), certain other types of acute leukaemia or related blood conditions, myelodysplastic syndrome (MDS) with excess abnormal cells after at least one round of treatment, or a high-risk bone marrow condition called myeloproliferative neoplasm (MPN) without severe scarring of the bone marrow or very enlarged spleen at the time of joining the trial (confirm with trial site)
• People whose leukaemia or related condition is currently in remission, meaning less than 5% abnormal cells are detected in the bone marrow (where required for the specific diagnosis)
• People who have a donor whose tissue type closely matches theirs (a full 8 out of 8 match at key immune markers), whether the donor is a family member or unrelated, and who is able to donate blood stem cells
• People who have read, understood, and signed the informed consent form for the trial
• People who are sexually active and capable of having children, who agree to use highly effective contraception (plus an additional barrier method such as a condom) from before joining the trial until after finishing immune-suppressing medications; men must also agree not to donate sperm and women must agree not to donate eggs during this period
• Women who could potentially become pregnant must not be pregnant or breastfeeding at the time of screening; women who have had a permanent sterilisation procedure or who have been through menopause (no periods for 12 months, in women over 45, without another medical explanation) are not considered to be at risk of pregnancy for the purposes of this criterion

Who may not be able to join:

For the higher-intensity treatment group:

• People with a poor overall health and activity level, as measured by a standard medical score (Karnofsky Score) below 70% (confirm with trial site)
• People with a high score on a transplant-specific health risk assessment tool called the HCT-CI, specifically a score above 5 (confirm with trial site)
• People whose cancer has spread to the brain or spinal fluid and has not responded to treatment directed at those areas
• People who test positive for HIV-1, HIV-2, HTLV-1, or HTLV-2 (certain viral infections)
• People with an active infection that is not under control and that an infectious disease specialist considers makes a stem cell transplant unsafe
• People with significant problems with kidney function, heart pumping function, lung function, or liver function that fall below specific medical thresholds (confirm exact thresholds with trial site); liver function problems will be reviewed by a stomach and bowel specialist, who will advise whether a transplant is considered safe
• People who have previously had a stem cell transplant from a donor
• People whose life expectancy is less than 12 months due to health conditions other than their blood cancer
• People with any other significant health conditions that the principal investigator considers would make a transplant unsuitable
• People with a known serious allergic reaction to any of the medications used in the trial, including cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF)
• People who have received a type of cancer treatment called checkpoint inhibitors within the three months before transplant, unless the principal investigator makes a specific exception

For the lower-intensity treatment group:

• People with a poor overall health and activity level, as measured by a standard medical score (Karnofsky Score) below 60% (confirm with trial site)
• People whose cancer has spread to the brain or spinal fluid and has not responded to treatment directed at those areas
• People who test positive for HIV-1, HIV-2, HTLV-1, or HTLV-2 (certain viral infections)
• People with an active infection that is not under control and that an infectious disease specialist considers makes a stem cell transplant unsafe
• People with significant problems with kidney function, heart pumping function, lung function, or liver function that fall below specific medical thresholds (note: the thresholds for kidney and heart function are slightly different from the higher-intensity group — confirm with trial site); liver function problems will be reviewed by a stomach and bowel specialist, who will advise whether a transplant is considered safe
• People who have previously had a stem cell transplant from a donor
• People whose life expectancy is less than 12 months due to health conditions other than their blood cancer
• People with any other significant health conditions that the principal investigator considers would make a transplant unsuitable
• People with a known serious allergic reaction to any of the medications used in the trial, including cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF)
• People who have received a type of cancer treatment called checkpoint inhibitors within the three months before transplant, unless the principal investigator makes a specific exception

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