Phase 1 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:

• Adults aged 18 or older
• People who have given written consent to participate
• People who have been diagnosed with a specific type of blood cancer affecting B-cells, including chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL), Waldenström's macroglobulinaemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or follicular lymphoma (FL)
• People with SLL, MCL, MZL, or FL who have at least one tumour that can be measured on a scan
• People whose cancer has either stopped responding to, or who could not tolerate, at least 2 previous cancer treatments
• People with a general health/activity level rated 0 to 2 on a standard medical scale (meaning able to carry out everyday activities with at most some limitation)
• People whose blood counts and organ function (blood cells, liver, and kidneys) meet certain minimum levels without needing transfusions or growth factor support
• People who are able to swallow tablets and commit to all study requirements for the full duration of the trial
• People of reproductive potential who are willing to use effective contraception throughout the study
• Male participants who agree not to donate sperm during the study and for 6 months after it ends
• People joining a specific part of the trial called Dose Expansion Cohort 3 who have previously been treated with pirtobrutinib (Jaypirca) for an approved use

Who may not be able to join:

• People whose blood cancer has transformed into a more aggressive form (such as Richter's transformation)
• People who have received another experimental or anticancer treatment within a certain period before the trial starts (within 5 half-lives for most treatments, or within 4 weeks for certain antibody therapies)
• People who are currently receiving, or plan to receive, another experimental treatment at the same time as this trial
• People who currently need blood-thinning treatment with warfarin
• People currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A4 inhibitors or inducers)
• People who have taken proton pump inhibitor medications (a common type of stomach acid medication) within 7 days before the first dose
• People currently taking certain other medications that affect how drugs are transported in the body (strong P-glycoprotein or BCRP inhibitors)
• People whose condition does not respond to blood transfusions
• People who have had major surgery within 4 weeks before the planned start of the trial
• People who have had a limited course of radiotherapy for symptom relief within 7 days before the first dose
• People who still have significant unresolved side effects from previous treatments (above a certain severity level), except for hair loss
• People who have had a stem cell transplant (from a donor or their own cells) or CAR-T cell therapy within the past 30 days
• People with another active cancer, unless it is in remission and life expectancy is greater than 2 years
• People whose lymphoma has spread to the central nervous system (brain or spinal cord)
• People with an active, uncontrolled immune condition causing low blood counts (such as autoimmune haemolytic anaemia or immune thrombocytopenic purpura) that required new or increased treatment within the 4 weeks before enrolment
• People with serious, uncontrolled heart or cardiovascular disease, or who have had a heart attack within the past 6 months, or who have certain abnormal heart rhythm readings on tests
• People with an active, uncontrolled infection (bacterial, viral, fungal, or parasitic)
• People who are HIV positive, or whose HIV status is unknown (HIV testing will be done at screening)
• People with a condition that significantly affects the body's ability to absorb medications through the digestive system
• People who are pregnant or breastfeeding
• People with a known allergy to any ingredient in the study drug (docirbrutinib)
• People who have previously been treated with docirbrutinib
• People in the Dose Escalation or Cohort 3 parts of the trial who have previously received a certain class of drug called a noncovalent BTK inhibitor, other than pirtobrutinib
• People in Dose Expansion Cohorts 1 and 2 who have previously received any noncovalent BTK inhibitor

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