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 diagnosed with certain types of CD20-positive B-cell non-Hodgkin lymphoma, confirmed by lab testing, including: Diffuse Large B-Cell Lymphoma (DLBCL) and its subtypes, High-Grade B-Cell Lymphoma (including "double-hit" or "triple-hit" types), Primary Mediastinal B-Cell Lymphoma, Follicular Lymphoma grade 3b, or a slower-growing lymphoma (follicular or marginal zone) that has transformed into one of these more aggressive types.
• People whose lymphoma has come back or stopped responding to treatment, and who have previously received chemotherapy including an anthracycline drug combined with an anti-CD20 antibody treatment.
• People who have had at least 2 prior lymphoma treatments, OR at least 1 prior treatment if their disease is considered high-risk (came back within 12 months or never responded to initial treatment) and a treating doctor has determined that CAR T-cell therapy is not suitable for them.
• Adults aged 18 or older.
• People with a general health and activity level that falls within a certain range, as measured by a standard scale used by doctors (ECOG performance status of 0, 1, or 2) (confirm with trial site).
• People with measurable disease that can be detected on scans.
• People whose blood counts and organ function meet certain minimum levels at the time of enrolment, without having received blood transfusions or certain blood-boosting injections in the 7–14 days before enrolment.
• People who are able and willing to use reliable contraception during treatment and for 12 months after finishing, and men who agree not to donate sperm for at least 12 months after the last dose.
• Women of childbearing potential who have a negative pregnancy test before starting the trial.
• People who are able to understand the study and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

• People who have previously been treated with a type of drug called a bispecific antibody that targets both CD3 and CD20.
• People who need to start urgent treatment to rapidly reduce their lymphoma right away.
• People who have received another lymphoma treatment less than two weeks before starting this trial (except steroid medicines used to manage symptoms).
• People who have had a donor (allogeneic) stem cell transplant, unless it was more than 180 days ago, there is no sign of graft-versus-host disease, and immunosuppressive medications from the transplant have been stopped for at least one month.
• People currently taking certain medications known to strongly affect how the body processes a drug called ibrutinib (strong CYP3A inhibitors or inducers), unless those medications can be stopped well in advance (confirm with trial site).
• People who have had major surgery within 4 weeks before starting treatment, unless it was surgery to diagnose lymphoma.
• People with known active lymphoma involvement in the brain or spinal cord.
• People with an active, uncontrolled infection or one that has required intravenous antibiotics for more than 2 days in a row within the 2 weeks before starting treatment.
• People with serious, uncontrolled heart conditions, including uncontrolled irregular heartbeat, significant heart failure, unstable chest pain, or a heart attack within the past 6 months; or significant blood vessel procedures (such as stenting) within the past 6 months.
• People with known liver cirrhosis with moderate to severe liver impairment.
• People with significant lung disease or a history of severe breathing problems requiring a breathing tube, or active lung inflammation.
• People who have had a stroke or mini-stroke within 6 months before starting treatment.
• People with any prior history of bleeding in the brain.
• People with known significant bleeding disorders or platelet function problems.
• People currently being treated with the blood-thinning medication warfarin (also called coumadin).
• People with a stomach or bowel condition that would interfere with swallowing or absorbing ibrutinib tablets, including an inability to swallow pills or capsules.
• People with a serious medical or mental health condition that, in the opinion of the trial team, could interfere with completing the treatment.
• People with a known allergy to any of the study medications or their ingredients.
• People who have previously had a solid organ transplant (such as a kidney or liver transplant).
• People with a history of another cancer that could interfere with the trial, in the opinion of the trial team.
• People who are currently taking part in another interventional clinical trial, or who have done so within 21 days of the first scheduled dose.
• People with a known history of HIV, or active hepatitis B or hepatitis C infection confirmed by specific blood tests.
• Women who are pregnant or breastfeeding.
• People who still have significant side effects (grade 2 or higher) from a previous cancer treatment.
• Children under 18 years of age, as safety data for this age group are not yet available.

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