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:

• People who have signed the required consent forms and are able to follow all study procedures, in the opinion of the study doctor
• People aged 18 or older
• People whose general physical functioning falls within an acceptable range on a standard medical scale (ECOG score of 0, 1, or 2 — confirm with trial site what this means for a specific situation)
• People with follicular lymphoma (FL) grades 1, 2, or 3A that has been confirmed by tissue testing and has not yet been treated
• People whose FL is at an advanced or widespread stage (Stage II with bulky or non-contiguous disease, Stage III, or Stage IV with bulky or high-burden disease)
• People whose lymphoma meets at least one criterion showing that whole-body (systemic) treatment is needed, such as: a large tumour mass (over 7 cm), three or more affected sites each at least 3 cm, symptoms such as unexplained fever, night sweats, or significant weight loss, an enlarged and uncomfortable spleen, symptoms caused by the mass pressing on nearby structures, organ damage linked to the lymphoma, low blood counts (low red blood cells, platelets, or white blood cells) caused by the lymphoma, or fluid build-up in the chest or abdomen
• People who, in their treating doctor's judgement, are considered a suitable candidate for chemoimmunotherapy (a combination of chemotherapy and immune-based treatment)
• People who have at least one tumour that can be measured in two directions on a CT or MRI scan (nodal tumours larger than 1.5 cm, or tumours outside lymph nodes larger than 1.0 cm)
• People who agree to provide tumour tissue samples, including agreeing to a biopsy before the first dose and a second biopsy approximately two to three weeks after the first dose, if the study doctor determines it is safe to do so (people who are unable or unwilling to have either biopsy may still be considered for participation after discussion with the principal investigator)
• People whose liver is functioning adequately, based on standard blood test results
• People whose bone marrow is functioning adequately, based on blood counts (people who do not meet these blood count levels due to lymphoma affecting the bone marrow may still be considered after discussion with the principal investigator)
• People whose kidneys are functioning adequately, based on blood or other test results
• Women who could become pregnant and who agree to use highly effective contraception (methods with a failure rate of 1% or less per year, supplemented by a barrier method) and to avoid donating eggs during treatment and for at least 3 months after the last dose of study medication — periodic abstinence and withdrawal are not accepted as contraception methods
• Men with female partners who could become pregnant or who are pregnant, who agree to remain abstinent or use a condom during treatment and for at least 60 days after the last dose of study medication, and who agree not to donate sperm during this period

Who may not be able to join:

• People whose FL is grade 3B or has transformed into a more aggressive type of lymphoma
• People whose FL does not meet the criteria for needing systemic treatment
• People who are not considered fit enough for chemoimmunotherapy, for reasons such as age or other health conditions
• People whose FL is found only in specific isolated locations, such as the duodenum (a part of the small intestine), the skin, or the testicles
• Children or adolescents with FL (this trial is for adults only)
• People who have previously received any treatment for their lymphoma
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant)
• People who have had an allogeneic stem cell transplant (a transplant using donor cells) within the past 5 years, or who are still taking medications to prevent transplant rejection (graft-versus-host disease prophylaxis)
• People who currently have, or have previously had, lymphoma affecting the brain or spinal cord
• People with a significant history of brain or nervous system conditions such as stroke, epilepsy, inflammation of brain blood vessels, or degenerative nerve diseases (some exceptions may apply — confirm with trial site)
• People with serious heart conditions, such as severe heart failure, a heart attack in the past 6 months, unstable heart rhythm problems, or unstable chest pain
• People with significant active lung disease, such as bronchospasm or obstructive lung disease
• People with a known active infection (bacterial, viral, fungal, or other) at the time of enrolment, or who have needed intravenous antibiotics or hospitalisation for an infection in the 4 weeks before the first dose
• People with a known or suspected long-term active Epstein-Barr virus infection
• People with test results showing an active or chronic hepatitis B virus (HBV) infection
• People with an active or chronic hepatitis C virus (HCV) infection (people who test positive for HCV antibodies but negative on a PCR test may still be considered — confirm with trial site)
• People with test results showing HIV infection
• People who have received a live, attenuated vaccine (such as the nasal flu vaccine) within 4 weeks before the first dose, or who are expected to need one during the study
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 3 months of the last dose of study medication
• People who have received radiation therapy recently, unless it was used only to manage urgent symptoms during the screening period and at least 2 weeks have passed since the last dose, with measurable disease still present outside the treated area
• People who have had major surgery within 4 weeks before the first dose (except for biopsies required by the study)
• People with a history of autoimmune disease (where the immune system attacks the body's own tissues), such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or others — some exceptions may apply for well-controlled or remote history of certain autoimmune conditions (confirm with trial site)
• People with a history of a serious immune reaction called haemophagocytic lymphohistiocytosis (HLH), or in whom the study doctor suspects this condition
• People with a confirmed history of progressive multifocal leukoencephalopathy (PML), a serious brain condition
• People who have had a severe allergic reaction or anaphylaxis to a monoclonal antibody therapy
• People with a history of another cancer, unless it was a skin cancer or cervical cancer treated with curative intent, early-stage prostate cancer, or another cancer that was treated with curative intent and has been in remission for at least 2 years
• People who have taken strong immune-suppressing medications within 2 weeks before the first dose (some exceptions apply for low-dose steroids and certain specific uses — confirm with trial site)
• People with a history of illicit drug or alcohol misuse within the 12 months before screening, in the study doctor's judgement
• People with any other serious medical condition or abnormal test result that, in the study doctor's judgement, would make participation unsafe or interfere with the study

For Cohort 2 of the trial only, additional criteria apply:

• People who need ongoing treatment with certain medications that strongly affect how the body processes a drug called zanubrutinib (confirm with trial site which medications are affected)
• People with a history of a serious bleeding disorder, such as haemophilia A, haemophilia B, or von Willebrand disease, or a history of spontaneous bleeding needing a transfusion or other medical treatment
• People who have had bleeding inside the skull within the 180 days before the first dose
• People who are unable to swallow capsules, or who have significant digestive system problems such as malabsorption, stomach or small bowel removal, bariatric (weight-loss) surgery, symptomatic inflammatory bowel disease, or bowel blockage
• People who have eaten grapefruit or grapefruit products, Seville oranges (including marmalade made with Seville oranges), or star fruit within 3 days before the first dose of zanubrutinib

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