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 chronic lymphocytic leukaemia (CLL) and whose condition has reached a point where treatment is needed, based on internationally recognised medical guidelines.
• People who are reasonably active and able to care for themselves, with a fitness level meeting a standard medical scoring system (score of 0, 1, or 2 out of 4).
• People whose bone marrow, liver, and blood count results are at acceptable levels (as defined by the trial), without relying on supportive treatments such as growth factor injections or blood transfusions — unless any abnormalities are clearly caused by the CLL itself.
• People with a life expectancy of more than 6 months.
• Women who could become pregnant must agree to use highly effective contraception (failure rate below 1% per year) or remain abstinent during treatment and for at least 3 months after the last dose of the study drugs, and must agree not to donate eggs during this period.
• Men must agree to use a condom or remain abstinent during treatment and must agree not to donate sperm, as defined by the trial protocol.

Additional criteria for Arm B of the trial:

• People who have been taking a type of targeted cancer medication called a BTK inhibitor for at least 12 months, whose CLL has continued to progress while on that medication, and whose treating doctor has determined they need further treatment. People in this group should be able to continue their BTK inhibitor at a stable dose during the screening period and for up to three cycles of the study treatment.

Additional criteria for Arm C of the trial:

• Participants must be based outside the United States.

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 3 months after the final dose of certain study drugs, or within 30 days after the final dose of venetoclax (if applicable).
• People who have previously received the study drug mosunetuzumab, any similar CD20/CD3-targeting antibody treatment, or an allogenic (donor) stem cell transplant.
• People who have received certain treatments within specific time periods before starting the study, including: radiation therapy within 2 weeks; an autologous (own cells) stem cell transplant within 100 days; CAR T-cell therapy within 30 days; certain antibody-based cancer treatments within 4 weeks; immune-suppressing medications within 2 weeks; or other cancer treatments within 4 weeks (note: some exceptions may apply for Arm B — confirm with trial site).
• People who have received a live or attenuated (weakened) vaccine within 4 weeks before the first dose, or who are expected to need one during the study or within 5 months after the final dose.
• People whose CLL has transformed into a more aggressive type of lymphoma.
• People who have had a severe or life-threatening allergic reaction to monoclonal antibody therapies in the past.
• People for whom one of the study drugs, tocilizumab, is medically unsuitable.
• People with a history of another cancer (certain exceptions may apply — confirm with trial site).
• People who have an active infection requiring antibiotic treatment through a drip (IV) or hospitalisation within the past 4 weeks, or who have a known active infection of any type at the time of joining the study (minor nail fungal infections are excepted).
• People with another significant health condition that could affect their ability to follow the study requirements or affect the study results.
• People who have had major surgery within 4 weeks before starting the study treatment (certain minor procedures required by the trial itself are excepted).
• People who have tested positive for COVID-19 (SARS-CoV-2) within 7 days before enrolling.

Additional exclusion criteria for Arm C of the trial:

• People who have received venetoclax within 12 months before starting the study treatment.
• People with a known HIV or HTLV-1 infection (testing for these may be required in certain countries).
• People with uncontrolled autoimmune anaemia or immune-related low platelet counts.
• People who have taken certain medications that strongly affect how the body processes drugs (known as strong or moderate CYP3A inhibitors or inducers) within 7 days before starting treatment.
• People who have used steroid medications for cancer treatment within 7 days before starting (inhaled steroids for asthma, topical steroids, and replacement steroids are excepted).
• People who have consumed grapefruit, Seville oranges (including marmalade), or star fruit within 3 days before the first dose, or who cannot avoid these foods throughout venetoclax treatment.
• People who are unable to swallow a large number of tablets.
• People who have a condition that prevents them from absorbing or taking medications by mouth.
• People who are allergic to both xanthine oxidase inhibitors and rasburicase (medications used to manage a treatment side effect).

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