Phase 2 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 over 18 years old who have been newly diagnosed with a specific type of blood cancer called AML (but not the M3 subtype), confirmed by tissue testing, including AML that developed from a previous blood disorder or as a result of prior cancer treatment
• People whose AML is currently in complete remission (the cancer is no longer detectable, with blood counts either fully or partially recovered)
• People who have received up to 6 cycles of standard induction and consolidation chemotherapy, or up to 12 cycles of a treatment combination called HMA plus venetoclax
• People who are able to start the trial treatment within 3 months of their most recent confirmed remission
• People who are not suitable candidates for a bone marrow transplant, for any reason (such as age, other health conditions, personal preference, or the type of AML they have)
• People whose heart is pumping at 50% or greater efficiency, confirmed by a heart scan
• People whose liver and kidney function fall within acceptable ranges on blood tests (confirm with trial site for specific values)
• People with an overall physical functioning score of 3 or below on a standard medical scale called the ECOG scale, meaning they are able to care for themselves at least part of the time
• Women who are not able to become pregnant (due to menopause, surgical removal of the uterus or ovaries, or having had their tubes tied), or women of childbearing age who have a negative pregnancy blood test before joining
• All participants who agree to use highly effective contraception during the treatment period and for at least 6 months after the last dose of the study drug

Who may not be able to join:

• People who have previously had an allogeneic bone marrow or stem cell transplant (a transplant using cells from a donor)
• People who have already received a high cumulative dose of a type of chemotherapy called anthracyclines — at or above 345 mg/m² in general, or at or above 295 mg/m² if they have also had radiation treatment to the chest area
• People diagnosed with a specific AML subtype called acute promyelocytic leukaemia (APL), identified by a chromosome change known as t(15;17)
• People who are unable to give informed consent due to a serious medical condition, abnormal lab results, or a psychiatric illness
• People with uncontrolled heart conditions, such as unstable heart disease, uncontrolled irregular heartbeat, valve problems not managed by medication, uncontrolled high blood pressure affecting the heart, or uncontrolled heart failure
• People with a history of Wilson's disease or any other condition involving abnormal copper levels in the body
• People who have had a significant allergic reaction to medicines similar in composition to cytarabine, daunorubicin, or liposomal drug products
• People with a history of another cancer, unless it was treated with curative intent, has shown no signs of return for at least 3 years, and is considered low risk for coming back — certain treated skin cancers, low-risk prostate cancer, or carcinoma in situ with no evidence of disease may be acceptable (confirm with trial site)
• People who still have unresolved side effects from previous cancer treatment that have not improved to a mild level or better (with the exception of hair loss)
• People with a known bleeding disorder such as von Willebrand's disease or haemophilia
• People with a known active hepatitis B or hepatitis C infection, or people who test positive on a specific virus-detection blood test (PCR) for either of these viruses
• People with any active, uncontrolled infection in the body
• People with any life-threatening illness, medical condition, or organ problem that, in the investigator's opinion, could put the person's safety or the study results at serious risk
• People with significant active heart disease, such as severe heart failure (Class 3 or 4), or who have had a heart attack, unstable chest pain, or an acute heart event within the past 6 months
• People whose leukaemia has spread to the central nervous system (brain or spinal cord)
• People who have a history of certain severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme
• People who are currently pregnant or breastfeeding
• People who are unwilling or unable to complete all required study visits, tests, and procedures
• People who are unable to understand the purpose and risks of the study or to provide signed consent
• People with moderate or severe liver impairment, classified as Child-Pugh Class B or C

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