Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the 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 score that measures treatment-related risk (called the HCT-Comorbidity Index) must be 5 or lower.
• People with a type of blood cancer called AML (diagnosed using 2022 WHO standards) where the disease did not respond to treatment, or has come back after treatment, including after certain standard chemotherapy or venetoclax-based therapies. People whose AML is in remission but where small amounts of cancer can still be detected by specialised tests may also be eligible. People with certain related types of acute leukemia that have also not responded to or have returned after treatment may also be eligible.
• People with blood conditions called MDS or CMML who have previously been treated with specific drugs called hypomethylating agents (such as azacitidine or decitabine) and whose disease did not respond, stopped responding, or came back — provided they received a minimum number of treatment cycles as specified. People with MDS or CMML who did not respond to at least one round of intensive chemotherapy may also be eligible. Those whose MDS or CMML has progressed into a secondary form of AML may also be eligible under certain treatment history conditions.
• People who have previously received certain chemotherapy regimens for MDS or AML; eligibility for those who previously received a specific regimen called CLAG-M or FLAG-Ida will be assessed individually by the lead study doctor.
• Use of a drug called hydroxyurea before starting the study treatment is permitted. People with very high white blood cell counts or related complications may receive certain limited treatments before joining.
• A functional status score (Karnofsky) of 70 or above, or an activity level score (ECOG) of 0 or 1, meaning the person is reasonably active and able to care for themselves.
• Adequate heart function, including no uncontrolled heart failure or irregular heart rhythms, and a heart pumping efficiency (ejection fraction) of at least 45%.
• Liver function within an acceptable range (bilirubin no more than 2.5 times the upper normal limit, with some exceptions allowed).
• Adequate lung function, with no need for supplemental oxygen and lung capacity measurements within specified ranges.
• Kidney function with a clearance rate above 60 mL/min.
• People who previously had a stem cell transplant using their own cells (autologous HCT), provided the disease returned more than 6 months after that transplant.
• People who previously had a donor stem cell transplant involving a type of radiation (TBI up to 3 Gy), provided it was more than 6 months ago.
• A suitable stem cell donor must already be identified and available — this may be a closely matched sibling, a matched or partially matched unrelated donor, or a half-matched (haploidentical) relative. Specific matching requirements apply to each donor type (confirm with trial site).
• Ability to understand and sign a consent form, or have a legal representative do so.
• Donors must meet specific compatibility and health standards, including age 18 or older and weight of at least 40 kg for half-matched (haploidentical) donors, and must pass screening according to relevant accreditation guidelines.
• Where more than one donor is available, selection follows a specific order of preference including factors like CMV status and blood type compatibility.

Who may not be able to join:

• People with active cancer involvement in the brain or spinal fluid (central nervous system disease).
• People with another serious illness that is likely to limit survival to less than one year.
• People with an active infection (bacterial, fungal, viral, or other) that is not being treated or is not considered stable or controlled. People whose fever appears to be caused by the blood cancer itself may still be eligible.
• People with a known allergy or medical reason preventing use of any of the drugs used in this trial.
• People who are pregnant or breastfeeding.
• People currently receiving any other approved or experimental treatment for leukemia.
• People with a half-matched (haploidentical) donor where antibody testing shows a high level of antibodies directed against the donor (called donor-specific antibodies or DSA), unless those levels can be reduced below a specified threshold with treatment before the transplant.

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