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 aged 18 or older who have been diagnosed with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or a rare blood cancer called BPDCN, confirmed by laboratory testing according to 2016 WHO guidelines
• People whose cancer cells have been tested within the past 3 months and shown to carry a specific protein called CD123 (also known as IL3RA)
• People aged 18 or older with AML that has come back or stopped responding to treatment (a prior course of a drug called hydroxyurea does not count as a previous treatment)
• People aged 18 or older with AML who have not yet had treatment and have either chosen not to have intensive chemotherapy, or whose other health conditions make intensive chemotherapy unsuitable for them
• People aged 18 or older with MDS who have more than 10% abnormal cells (called blasts) in their bone marrow
• People aged 18 or older with BPDCN that has come back or stopped responding to treatment
• People whose major organs (kidneys, liver, and heart) are working well enough to meet the trial's specific blood test and heart scan thresholds (confirm specific values with trial site)
• For AML and BPDCN groups: people whose white blood cell count is below 20,000 per microlitre on the day treatment starts (hydroxyurea may be used beforehand to bring this down)
• People who are able to understand the trial and are willing to sign a written consent form
• People who are able to attend all required study visits and follow-up appointments
• Women who could become pregnant must agree to use reliable contraception during the trial and for 2 months after treatment ends
• Men must also agree to use reliable contraception during the trial and for 2 months after treatment ends

Who may not be able to join:

• People in the AML or BPDCN groups who have previously been treated with a drug called venetoclax, unless it was last taken more than 2 months before the trial treatment starts
• People diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia
• People who have received chemotherapy, radiation, or biological cancer therapy within 14 days before the trial treatment starts (intrathecal chemotherapy and hydroxyurea are exceptions)
• People who have had a stem cell transplant within the past 60 days, or who are currently experiencing graft-versus-host disease
• People whose AML or BPDCN has spread to the brain or spinal fluid (people with BPDCN will need a spinal fluid test as part of screening; people with a past history of cancer in the brain or spinal fluid must have had two clear spinal fluid tests since that time)
• People who are known to be HIV positive, or who have an active hepatitis B or hepatitis C infection
• People with significant heart or lung conditions, including poorly controlled heart failure, angina, high blood pressure, irregular heartbeat, or a heart attack or stroke within the past 6 months, or certain abnormalities on a heart tracing (ECG) (confirm specific thresholds with trial site)
• People with a known active serious solid tumour cancer (skin cancers such as basal cell or squamous cell cancer, and early-stage cancers that have not spread, are generally not excluded — confirm with trial site)
• People with another blood cancer that currently requires treatment
• People who are pregnant (a pregnancy test will be required within 14 days of starting the trial)
• People who are currently breastfeeding
• People with an infection that is not yet under control (people with infections that are being successfully treated may still be considered — confirm with trial site)
• For AML and BPDCN groups: people with digestive system conditions that prevent them from swallowing and absorbing oral medication, or who require feeding through a drip, or who have uncontrolled inflammatory bowel conditions such as Crohn's disease or ulcerative colitis
• For AML and BPDCN groups: people who have taken certain medications known as strong CYP3A inducers within 7 days before the trial treatment starts (confirm which medications are affected with the trial site)

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