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:

• People who are able to understand the nature of the study and agree to take part by signing a consent form (either themselves or through a legal representative), and who also consent to having biological samples stored in a research repository
• People of any race, ethnicity, or gender identity who have been newly diagnosed with a specific type of blood cancer called monocytic AML (confirmed by tissue testing under World Health Organization guidelines), or who have AML with certain gene mutations (in N/KRAS, FLT3 ITD/TKD, NF1, PTPN11, or CBL)
• People who are not suitable for, or who do not wish to receive, standard intensive chemotherapy — this includes people aged 75 or older, or people aged 18–74 who have one of the following: a low physical functioning score, a serious heart condition, a serious lung condition, reduced kidney function, a liver problem with elevated bilirubin levels, or another health condition the treating doctor considers incompatible with intensive chemotherapy
• People aged 75 or older who meet minimum kidney function, liver function, and general physical functioning requirements at the time of screening
• People who are willing and able to provide bone marrow samples, including samples for research purposes
• People who are willing to receive supportive and preventive care for blood-related side effects, infections, and related complications
• People who are willing to follow the study schedule, provide biological samples as required, and follow any lifestyle restrictions during treatment
• People who test negative for pregnancy at the screening visit and within 24 hours of starting treatment (for people who could become pregnant), given that the study drugs carry potential risks to a developing baby
• People who are willing to use approved contraception throughout treatment and for a specified period afterward, as detailed by the trial (timeframes vary depending on which study drug was last received)

Who may not be able to join:

• People whose AML has spread to the central nervous system and is causing symptoms
• People who have previously received treatment for AML, with the exception of certain limited treatments used to reduce high white blood cell counts (such as hydroxyurea, blood cell growth factors, or a procedure called leukapheresis)
• People who have had another active cancer within the five years before starting the trial
• People who have received an investigational (experimental) treatment within 28 days before starting the trial, or within 5 half-lives of that treatment if known
• People who have had major surgery within 28 days, or a stem cell transplant within 100 days, before starting the trial (routine procedures such as biopsies or lumbar punctures are not considered exclusionary)
• People who have a known allergy or sensitivity to any of the study drugs (cladribine, cytarabine, venetoclax, or azacitidine) or their ingredients
• People who have received a treatment targeting a protein called BCL-2 for any previous condition or cancer within the past five years
• People with conditions that affect their ability to swallow or absorb oral medications, such as difficulty swallowing, short-gut syndrome, or slow stomach emptying
• People currently taking medications known to interact harmfully with the study drugs, particularly certain drugs that strongly affect how the body processes medications (confirm specific medications with the trial site)
• People with an infection that is not under control; people with a controlled infection must have been free of fever and medically stable for at least 72 hours before starting the trial
• People with an active hepatitis B or hepatitis C infection (those with evidence of chronic infection may be considered individually by the lead researcher)
• People who are HIV-positive and are currently taking antiretroviral therapy or other treatments that may interfere with how the study drugs are processed by the body
• People who are pregnant at the time of enrolment, or who are unwilling to stop breastfeeding (breastfeeding would need to stop from the start of treatment until one week after the last dose of any study drug)
• People with other serious uncontrolled health conditions, including unstable heart or lung problems, uncontrolled infection, or a mental health or personal situation that could make it difficult to follow the study requirements

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