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:

• People who have been diagnosed with a type of blood cancer called CLL (Chronic Lymphocytic Leukaemia) or SLL (Small Lymphocytic Lymphoma), or a closely related variant, based on recognised 2018 diagnostic standards.
• People who have been treated with a second-generation BTK inhibitor (specifically acalabrutinib or zanubrutinib), with or without a drug called obinutuzumab, for at least 12 months as their first treatment for CLL/SLL.
• People whose cancer has responded partially or better to that treatment, but where some cancer cells can still be detected in the blood or bone marrow using a sensitive genetic test called NGS ClonoSEQ.
• People aged 18 years or older.
• People who are well enough to carry out basic daily activities, as measured by standard medical rating scales (confirm with trial site).
• People whose heart, liver, kidneys, and bone marrow are functioning at levels that meet the trial's minimum thresholds, as assessed by blood tests (confirm with trial site).
• People of childbearing potential who are willing to use at least one reliable form of contraception throughout the trial and for four months after finishing the study treatment — acceptable methods include complete abstinence, a surgically sterile partner, an intrauterine device (IUD), or hormonal contraception used for at least one month before starting treatment.
• Women of childbearing potential who have a negative pregnancy test (from a blood sample taken within seven days before the first dose).
• Males who are not surgically sterile and who are willing to avoid donating sperm from the start of treatment until four months after the last dose.
• People who are able to understand the trial information and are willing to sign a consent form (a legally authorised representative may sign on a participant's behalf if needed).

Who may not be able to join:

• People whose cancer has completely disappeared (a complete response) or has shown no detectable disease in the blood or bone marrow after treatment with a second-generation BTK inhibitor, as measured by the NGS ClonoSEQ test.
• People whose CLL cells do not carry a protein called CD20 on their surface before treatment.
• People who have previously received any treatment with a type of drug called a CD3×CD20 bispecific antibody.
• People who have had an organ transplant, unless they have had no active graft-versus-host disease requiring treatment in the 12 months before joining the trial.
• People who have received a live vaccine within 28 days before starting the study treatment.
• People who have an autoimmune disease that requires high doses of immune-suppressing medication (for example, more than 20 mg of prednisone daily).
• People with active disease affecting the central nervous system (brain or spinal cord), unless the trial investigator determines this would not prevent participation.
• People with a known allergy or sensitivity to any component of the trial drugs (confirm with trial site for full ingredient lists).
• People whose CLL has transformed into a more aggressive form of cancer called Richter's transformation. (Note: people with accelerated-phase CLL or prolymphocytic progression are not excluded.)
• People who have previously received radiation therapy, unless the investigator determines this would not affect their ability to participate.
• People who need to take blood-thinning medication with warfarin or a similar vitamin K antagonist drug.
• People who have had major surgery within 14 days before the first dose of the study drug.
• People with significant heart problems, such as uncontrolled or symptomatic irregular heartbeat, heart failure, or a heart attack within the past 180 days, or with severely reduced heart function as measured by standard cardiac assessments (confirm with trial site).
• Women who are pregnant, planning to become pregnant during the study, or currently breastfeeding.
• People with an active, uncontrolled infection (bacterial, viral, fungal, or other), or who have started new intravenous antibiotic treatment within two weeks before the first dose.
• People with poorly controlled HIV, or active hepatitis B or C infection, as defined by specific blood test results (confirm with trial site).
• People who have had an unexplained fever above 38.3°C within seven days before the first dose (fevers clearly linked to the cancer or a known infection may be assessed individually by the investigator).
• People who have, or have previously had, another type of cancer whose progression or treatment could affect how safely or accurately the trial can be evaluated, in the opinion of the investigator.

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