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:

• Adults aged 18 or older; for those over 60, a health scoring tool (HCT-CI) must show a score of 5 or below; people aged 75 or older would need their case reviewed and approved at a special medical team meeting before joining
• People diagnosed with a type of blood cancer called acute myeloid leukemia (AML) whose cancer has not responded to at least two rounds of standard chemotherapy, or whose cancer has come back after treatment (including those whose blood counts look normal but tests still detect signs of disease)
• People with a related type of blood cancer called acute leukemia of ambiguous lineage whose disease has not responded to treatment or has come back
• People with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) who have already been treated with at least one standard drug from a class called hypomethylating agents (such as azacitidine or decitabine) and whose disease did not respond or came back — or who have tried at least one round of intensive chemotherapy
• People who have received a medication called hydroxyurea before starting the trial, or who may need a procedure to reduce very high white blood cell counts before starting
• People with a general health and activity level meeting a score of 70 or higher on the Karnofsky scale, or 0–1 on another standard health scoring system (ECOG) (confirm with trial site)
• People whose heart is functioning adequately, with no uncontrolled heart failure or irregular heartbeat, and with the heart's pumping strength at 45% or above
• People whose liver function tests are within acceptable limits (or slightly outside them only if there is a specific medical explanation)
• People whose lungs are functioning well enough, with no need for supplemental oxygen and lung capacity measurements meeting set thresholds (confirm with trial site for exact values)
• People whose kidney function blood test result is 1.5 mg/dL or below
• People who have previously had a stem cell transplant using their own cells, as long as the cancer came back more than 3 months but no more than 6 months after that transplant
• People who have previously had a stem cell transplant from a donor that included a low dose of whole-body radiation (up to 3 Gy), as long as it was more than 6 months ago
• People who have a suitable stem cell donor identified and available — this may be a closely matched family member, an unrelated matched donor, a half-matched (haploidentical) family member, or a matched cord blood unit
• Women who could become pregnant and men must agree to use reliable contraception from the time of signing consent until at least 12 months after the transplant
• People who have previously received certain chemotherapy regimens for AML or MDS; if a specific regimen called CLAG-M or FLAG-Ida was used before and the disease responded to it, eligibility would be decided individually by the lead researcher
• People who are able to understand and sign an informed consent form, or who have a legal representative who can do so on their behalf
• People who have a suitable donor who meets the specific matching and health requirements set out by the trial (detailed donor matching rules apply — confirm with trial site)

Who may not be able to join:

• Adults being treated at Seattle Children's Hospital
• People who currently have cancer that has spread to the brain or spinal fluid (active central nervous system disease)
• People with another serious illness where life expectancy is estimated to be less than one year
• People with an active, uncontrolled infection caused by fungus, bacteria, a virus, or other organism (those with a fever believed to be caused by the blood cancer itself may still be eligible)
• People with a known allergy or medical reason to avoid any of the medications used in this trial
• People who are currently pregnant or breastfeeding
• People currently receiving any other treatment — approved or experimental — aimed at treating leukemia
• People with a half-matched (haploidentical) donor where blood tests show a high level of antibodies directed against the donor's cells (called donor-specific antibodies); those with lower levels after a treatment to reduce those antibodies may still be considered eligible (confirm with trial site)

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