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 been diagnosed with acute myeloid leukemia (AML), or a related blood disorder called MDS/AML with a specific level of abnormal cells, confirmed using standard 2022 classification systems.
• Adults aged 18 or older whose AML or MDS/AML has come back or stopped responding to previous treatment, and for whom no standard treatment options remain (excluding a specific type called acute promyelocytic leukemia).
• People whose disease has relapsed (returned) or is refractory (did not respond), as confirmed by blood or bone marrow tests, and who have already received an appropriate number of cycles of specific prior treatments such as intensive chemotherapy, venetoclax-based regimens, or other recognised treatment combinations.
• Younger or fitter patients in their first relapse after intensive chemotherapy, where that first period of remission lasted 12 months or less.
• People whose disease has relapsed with a specific gene mutation called TP53, regardless of how long their first remission lasted.
• Older or less fit patients who relapse while on a maintenance treatment combining HMA and venetoclax, regardless of how long their first remission lasted.
• People with a performance status rated 0 to 2 on the ECOG scale, meaning they are able to carry out daily activities with little to no limitation (confirm with trial site).
• People who have previously had a stem cell transplant from a donor may be considered, provided they have fully recovered from transplant-related side effects, are no longer taking immune-suppressing medications (or have stopped for the required period), and have no more than mild (grade 1) chronic graft-versus-host disease. A very low dose of steroids may be acceptable (confirm with trial site).
• People whose leukemia has a specific targetable gene mutation (such as FLT3 or IDH1/2) may be considered after they have already tried all appropriate approved treatments for that mutation.
• People who previously had a blood disorder such as aplastic anemia, MDS, CMML, or a related condition, who received appropriate AML-level treatment for that disorder and whose condition has since progressed to AML.
• People whose liver is functioning adequately, based on specific blood test results within defined ranges.
• People whose kidneys are functioning adequately, with a kidney filtration rate of at least 45 mL/min as calculated by standard medical formulas.
• People who are willing and able to use effective contraception throughout the trial and for a set period after treatment ends. This applies to women who could potentially become pregnant (generally those aged 8 to 55 who have not gone through menopause or had certain surgical procedures) and to men, who must use contraception for at least 4 months after treatment ends.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People whose leukemia has a specific chromosomal change called t(15;17).
• People with a white blood cell count above 15 x 10⁹/L at the time of starting the trial (though certain medications may be used beforehand to bring this count down).
• People who have received chemotherapy, targeted therapy, radiation, immunotherapy, or other trial treatments within the 2 weeks before starting this trial, or who have not yet recovered from side effects of prior treatment.
• People with leukemia that has spread to the central nervous system (brain and spinal cord) and is causing symptoms or is not under control.
• People who have an active infection (fungal, bacterial, viral, or other) that is still causing symptoms and has not improved despite treatment.
• People with serious stomach or gut conditions that could interfere with absorbing oral medications, or a history of chronic diarrhoea, colitis, inflammatory bowel disease, or similar conditions (people with a past history of such conditions may be assessed individually by the trial team).
• People with serious, uncontrolled health conditions such as severe heart failure, significant uncontrolled heart rhythm problems, acute breathing failure, or unstable lung disease.
• People with a currently active hepatitis B or hepatitis C infection with detectable virus levels in the blood, or a known HIV infection.
• People with decompensated heart failure, low potassium levels, a prolonged heart electrical interval (QTc above 450 ms for men or 470 ms for women), long QT syndrome, or a history of a specific dangerous heart rhythm called Torsades de pointes. (People with certain heart conduction conditions or a pacemaker may still be considered after specialist review — confirm with trial site.)
• People with a history of another cancer, unless they completed curative treatment at least 1 month before joining the trial and have no signs of remaining disease. Certain lower-risk cancers treated with curative intent may be considered immediately after completion of treatment and full healing (confirm with trial site).
• People who have had major surgery within 4 weeks before screening, or who have a significant wound that has not fully healed.
• People under a legal protection order, those with uncontrolled psychiatric conditions, ongoing illicit substance use, or anyone unable or unwilling to follow the trial's treatment schedule and requirements.
• People with a known severe allergy or sensitivity to any component of the study medications.
• Women who are breastfeeding, women who could become pregnant and have a positive pregnancy test, or women who could become pregnant and are not willing to use adequate contraception.
• Women who are pregnant.
• Close family members (first-degree relatives) of the trial investigators, trial staff, or the industry sponsor.

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