Phase 2 Lymphoma 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:

• Adults aged 18 years or older.
• People who have been diagnosed with CLL (Chronic Lymphocytic Leukaemia) or SLL (Small Lymphocytic Lymphoma) according to specific 2018 medical guidelines.
• People who have already received treatment for CLL/SLL and now need further therapy based on those same guidelines.
• People who are able to swallow and take oral (by mouth) medications.
• People who are willing and able to give their informed, signed consent and follow the study requirements.
• Previous or ongoing treatment with certain targeted therapies called BTK inhibitors or BCL2 inhibitors is allowed but not required (confirm with trial site for specific timing requirements).
• People who have had previous combination therapy involving BTK inhibitors, BCL2 inhibitors, and/or anti-CD20 antibodies, provided at least six months have passed since completing that combination (confirm with trial site).
• People who previously received venetoclax and achieved at least a partial response to it.
• People whose side effects from past treatments have largely resolved (down to a mild level or better), with exceptions allowed for hair loss and mild nerve-related symptoms.
• People with a general health and activity level rated at a certain functional level (ECOG score of 2 or below — meaning able to carry out some self-care but may not be able to do heavy physical activity) (confirm with trial site).
• People whose kidneys and liver are functioning at an adequate level based on blood tests.
• People whose blood counts (platelets, white blood cells, and haemoglobin/red blood cells) meet minimum levels on testing.
• People whose blood clotting measures fall within an acceptable range on testing.
• Women who could potentially become pregnant must have a negative pregnancy blood test at screening and again within 7 days before starting the study drugs, and must agree to use two forms of contraception (one highly effective method plus a barrier method) during treatment and for 6–12 months after the last dose (confirm with trial site for exact timeframes per medication).
• Women who cannot become pregnant (post-menopausal for at least 1 year, or who have had a tubal ligation or hysterectomy) are also eligible.
• Men whose partners could become pregnant must agree to use effective contraception during the study and for 30 days after the last dose.

Who may not be able to join:

• People whose CLL/SLL got worse (progressed) while they were being treated with venetoclax.
• People who have a history of, or currently have, a condition called Richter's Syndrome (where CLL transforms into a more aggressive type of lymphoma).
• People who have a known allergic reaction to any of the study drugs (pirtobrutinib, venetoclax, or obinutuzumab) or their ingredients.
• People with known or suspected involvement of CLL/SLL in the brain or central nervous system.
• People with a history of abnormal or excessive bleeding disorders.
• People who had a serious or life-threatening bleeding event while previously taking a BTK inhibitor.
• People who have had a stroke or bleeding in the brain within the past 6 months.
• People who are currently taking blood-thinning medication such as warfarin or other vitamin K antagonists.
• People who have had major surgery within 4 weeks of the planned study start.
• People with significant medical conditions affecting the kidneys, nervous system, mental health, hormonal system, metabolism, or immune system that, in the investigator's judgement, could affect safety or study results.
• People who have received a stem cell transplant or CAR-T cell therapy within the past 60 days, or who have ongoing complications from those treatments such as graft-versus-host disease, incomplete blood count recovery, or need for ongoing immune-suppressing medications above a certain dose.
• People with active, uncontrolled immune conditions that cause the body to attack its own blood cells, where new or increased treatment was needed within the past 4 weeks.
• People who experienced a severe heart rhythm problem (grade 3 or above) while on a previous BTK inhibitor.
• People with significant heart conditions, including unstable angina or a heart attack in the past 6 months, a significantly reduced heart pumping function, severe heart failure, or uncontrolled or symptomatic abnormal heart rhythms.
• People whose heart's electrical interval (called QTcF) is abnormally prolonged on an ECG (heart tracing) during screening.
• People with active hepatitis B or hepatitis C infection confirmed by screening blood tests.
• People with other significant uncontrolled medical conditions, including active serious infections, that in the investigator's opinion could pose a risk during the study.
• People with a known HIV infection, or people whose HIV status is unknown and who test positive at screening.
• People with a known active CMV (cytomegalovirus) infection.
• People who have received a live vaccine within 28 days before enrolling.
• People with conditions that significantly affect the body's ability to absorb medications taken by mouth.
• People with another active cancer, unless it has been in remission with a life expectancy of more than 2 years (certain skin cancers and early-stage cervical or breast cancers may be exceptions — confirm with trial site).
• People currently taking strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inhibitors or inducers), or certain other specific medications listed as P-gp inhibitors, without an appropriate washout period.
• People who regularly consume grapefruit, Seville oranges, or star fruit, or plan to during the study.
• People who are pregnant or planning to become pregnant during the study or within 1 month of the last dose.
• People who are breastfeeding or planning to breastfeed during the study or within 1 week of the last dose.

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