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 been diagnosed with a type of aggressive blood cancer called CD20-positive Diffuse Large B-Cell Lymphoma (DLBCL) or a closely related type, and have not yet received treatment for it.
• People whose cancer has been classified under one of several specific subtypes according to a standard medical classification system used in 2016 (confirm with trial site for which subtypes apply).
• People who have a tumour tissue sample available — either one collected within the past 90 days or a fresh sample taken before joining the study.
• People whose cancer is considered intermediate to high risk, based on a scoring system called the IPI, with a score between 2 and 5.
• People who are reasonably well and able to carry out daily activities, as measured by a standard scale called the ECOG Performance Status (scores 0, 1, or 2).
• People who are 18 years of age or older at the time of signing the consent form.
• People whose heart is pumping at least 50% of its normal capacity, confirmed by a heart scan.
• People whose blood counts meet certain minimum levels — including red blood cells, white blood cells, and platelets — without needing a blood transfusion in the 14 days before the first treatment (some exceptions may apply if the cancer itself is affecting bone marrow or the spleen).
• People whose liver and kidney function results fall within acceptable ranges on blood tests.
• People who have at least one measurable area of lymphoma that is visible on a PET/CT scan and is larger than 1.5 cm.
• Women who could become pregnant must agree to use highly effective contraception during treatment and for a set period afterwards (the longer of: 12 months after the last dose of the main drug combination, 2 months after the last dose of glofitamab, or 9 months after the last dose of polatuzumab).
• Men must agree to use a condom and not donate sperm during treatment and for the same period as described above, and must discuss fertility preservation options with the trial team before starting.
• People with a chronic hepatitis B infection must have an undetectable level of the virus while on suppressive treatment, and must agree to monthly monitoring and antiviral treatment if needed.
• People with a history of hepatitis C must have an undetectable viral load at the time of joining.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have a known allergy or serious reaction to any of the study drugs, including a previous reaction to anthracycline-based chemotherapy, monoclonal antibodies, or corticosteroids such as dexamethasone.
• People who have previously had an organ transplant.
• People with a history of a slower-growing (indolent) lymphoma, or who have been diagnosed with certain other specific types of lymphoma, including Burkitt lymphoma, grey-zone lymphoma, primary mediastinal large B-cell lymphoma, lymphoma affecting the brain or spinal cord, or certain other related conditions.
• People who have already received treatment for DLBCL, with limited exceptions — short-term steroid treatment of up to 7 days, or one cycle of a specific chemotherapy combination called R-CHOP, may be acceptable (confirm with trial site).
• People who have previously had radiation therapy to the chest or the area around the heart.
• People who have received chemotherapy drugs within the past 5 years for any medical condition, or who have previously received an anti-CD20 antibody treatment.
• People who have received any monoclonal antibody treatment within the past 3 months, any experimental therapy within the past 28 days, or a live vaccine within the past 28 days before starting the trial.
• People who are currently taking high-dose steroid medication (more than 30 mg per day of prednisone or equivalent) for reasons other than managing lymphoma symptoms, unless the dose has been stable for at least 4 weeks (specific rules apply — confirm with trial site).
• People with a history of another cancer, unless it was treated successfully with no signs of return for at least 2 years, was a treated skin cancer or carcinoma-in-situ with no current evidence of disease, or is a low-risk localised prostate cancer being monitored but not actively treated (other exceptions may be considered by the lead investigator).
• People who are pregnant or breastfeeding. A pregnancy test must be done within 7 days before starting treatment, and the result must be negative.
• People who currently have an active infection, or who have recently been hospitalised or treated with intravenous antibiotics for an infection within the 2 weeks before starting the trial.
• People who are known to be HIV-positive or to have HTLV-1 (a related virus); testing for HTLV-1 is required for people from certain regions where this virus is more common.
• People with significant liver disease, including active viral hepatitis, liver cirrhosis, or current alcohol misuse.
• People with serious or poorly controlled other medical conditions, particularly heart conditions such as heart failure classified as moderate to severe, a heart attack within the past 6 months, unstable heart rhythms, unstable chest pain, or significant lung disease.
• People with a known history of neurological conditions including stroke or bleeding in the brain within the past 3 months, or a seizure disorder.
• People who already have moderate or severe nerve damage (peripheral neuropathy, grade 2 or above) or a specific inherited nerve condition called Charcot-Marie-Tooth disease (demyelinating type).
• People who have had major surgery within 4 weeks before starting the trial, unless that surgery was done solely to obtain a tissue sample for diagnosis.
• People with an active autoimmune disease that currently requires treatment (exceptions may apply for people with stable thyroid conditions on thyroid medication, or type 1 diabetes on a stable insulin dose).
• People with a known or suspected history of a rare immune condition called haemophagocytic lymphohistiocytosis (HLH).

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