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 or older.
• People who are willing and able to sign a consent form and follow the study requirements.
• People whose lymphoma can be measured on a scan, with at least one affected lymph node larger than 2.0 cm or one affected area outside the lymph nodes larger than 1.0 cm.
• People joining the active treatment group must have lymphoma visible on scans in more than one area of the body.
• People whose Large B Cell Lymphoma has come back or stopped responding to a specific type of immunotherapy called CAR-T cell therapy (targeting CD19), within 6 weeks before joining the study.
• People joining the active treatment group must have blood counts at or above minimum levels for red blood cells (haemoglobin ≥ 80 g/L), platelets (≥ 75 x 10⁹/L), and white blood cells called neutrophils (≥ 1.0 x 10⁹/L) — these levels may be supported by transfusions or growth factor treatments as needed.
• People joining the active treatment group must have a general health status rated at 2 or below on a standard medical scale (ECOG), meaning someone who is up and about and capable of self-care, even if unable to carry out heavy physical work (confirm with trial site).
• People with liver enzyme levels (AST and ALT) within an acceptable range at screening.
• People with bilirubin levels within an acceptable range at screening, with an exception for those with a diagnosed condition called Gilbert's syndrome.
• People with kidneys functioning at an adequate level, measured by a standard calculation of kidney clearance rate (confirm with trial site).

Who may not be able to join:

• People with a life expectancy of less than 30 days at the time of joining.
• People who have previously been treated with a BTK inhibitor or a PD-1 inhibitor at any point.
• People who have previously had a severe allergic reaction to a type of medication called a monoclonal antibody.
• People in the active treatment group who are taking prednisone at doses higher than 10 mg per day for at least 7 days before starting treatment; people in the standard care group may only take prednisone for symptom management.
• People with an autoimmune disease that is not well controlled.
• People with known active lymphoma involvement in the brain or spinal cord.
• People who have previously had a bone marrow transplant from a donor, or any organ transplant.
• People with active bleeding, a history of serious bleeding disorders (such as haemophilia or von Willebrand disease), or a history of stroke or bleeding in the brain within the past 180 days.
• People who have difficulty swallowing tablets or capsules, or who have a digestive condition that would affect how the body absorbs oral medication.
• People with a long-term or currently active infection (bacterial, viral, or fungal) that is not controlled, or who test positive for a virus called human T-cell lymphotropic virus type 1 (HTLV-1).
• People with signs of active hepatitis B infection; people who test positive for a hepatitis B marker called HBcAb (but not HBsAg) may still be considered if the hepatitis B virus is undetectable in the blood and they are willing to take preventive medication and be monitored (confirm with trial site).
• People with active hepatitis C infection; those with a hepatitis C antibody may still be considered if the virus is undetectable in the blood (confirm with trial site).
• People with known active HIV infection may still be considered if their immune cell counts and virus levels are well controlled (confirm with trial site).
• People with serious heart conditions, including certain abnormal heart rhythms, a recent heart attack within the past 6 months, heart failure, very high blood pressure that is not controlled, or certain electrical conduction problems in the heart.
• People who have had a significant stroke or bleeding in the brain within the past 6 months.
• People who have had another active cancer within the past 2 years, with some exceptions for certain skin cancers or other cancers that were treated locally with the intent to cure.
• Women who are able to become pregnant and are not willing to use highly effective contraception from before the first dose until at least 120 days after the last dose of study treatment.
• Men who have not had a vasectomy and are not willing to use barrier contraception and a highly effective contraceptive method during treatment and for at least 120 days after the last dose of study treatment.
• People who have had major surgery within 4 weeks before starting the study drug.
• People who have received a live vaccine within 28 days before starting the study drug.
• People who require treatment with warfarin or similar blood-thinning medications.
• People with severe breathing difficulties, significant shortness of breath at rest, or serious lung disease.
• People with a history of a lung condition called interstitial lung disease, non-infectious inflammation of the lungs, or lung scarring — unless caused by radiation therapy.
• People with any illness or condition that the study doctor believes could affect safety or interfere with the study results.
• People with active or severe autoimmune diseases (such as lupus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, and others); some milder autoimmune or immune-related conditions (such as vitiligo, eczema, type 1 diabetes, or thyroid conditions managed with replacement hormones) may still be considered (confirm with trial site).
• People currently taking high-dose steroid medications or other immune-suppressing medications within 14 days of starting the study drug, with some exceptions for low-dose replacement therapy or locally applied steroids.
• People with known contraindications to either of the two study drugs, zanubrutinib or tislelizumab.
• Women who are pregnant or breastfeeding.
• People with a known allergy or sensitivity to zanubrutinib, tislelizumab, or any ingredients in the study drugs.
• People who still have side effects from previous cancer treatments that have not returned to their normal baseline or stabilised.
• People with uncontrolled diabetes, significant abnormalities in potassium, sodium, or calcium blood levels, or severely low albumin levels in the blood in the 14 days before joining the study.

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