Phase 3 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 fully informed about the trial and are willing to sign a consent form
• People aged 18 to 75 years (men and women are both eligible)
• People who have been confirmed by a specialist pathology review to have a type of blood cancer called diffuse large B-cell lymphoma (DLBCL), based on the 2022 World Health Organization classification (people who relapsed more than one year ago will need a new tissue biopsy to confirm the diagnosis)
• People who have measurable areas of cancer that can be seen on specific scans (CT, MRI, or PET-CT), where the affected lymph nodes measure more than 15mm and other affected areas measure more than 10mm
• People whose DLBCL has come back or stopped responding to treatment after at least one prior treatment course, and where at least one of those prior treatments included a CD20 antibody therapy (confirm with trial site for the specific definitions of "relapsed" and "refractory")
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities)
• People whose life expectancy is estimated to be more than 12 weeks
• People whose blood counts, liver function, and kidney function meet the required levels as assessed by blood tests (confirm with trial site for specific values)

Who may not be able to join:

• People with a known serious allergy to the study drug or any of its ingredients
• People (men or women) who plan to have children within 5 years and have not preserved sperm or eggs beforehand, unless future research confirms the drug is safe for reproduction
• Women who are pregnant or breastfeeding
• People whose lymphoma started in the brain or spinal cord (primary central nervous system lymphoma)
• People whose DLBCL has spread to the brain or the lining of the brain at the time of screening
• People who have another active cancer that requires treatment and could interfere with the study
• People who received certain other targeted drug treatments within 2 weeks before joining
• People who have previously been treated with BEBT-908, R-ICE, or R-GemOx
• People who had a stem cell transplant using their own cells within the past 3 months
• People who received radiotherapy within the past 3 months that could affect how the study measures results, or radiotherapy that has affected bone marrow function
• People who received chemotherapy or biological cancer therapy within the past 3 weeks
• People who used certain traditional Chinese medicines or herbal medicines with anti-tumour effects within the past 2 weeks
• People who had major surgery (other than a tumour biopsy) within the past 4 weeks, or whose surgical side effects have not yet settled
• People who received certain blood cell-boosting injections (such as G-CSF or GM-CSF, or TPO) within the past 2 weeks (note: people who started certain red blood cell-boosting treatments within the past 2 weeks may still be eligible — confirm with trial site)
• People who received steroid medication (such as prednisone) at a dose above 10mg per day within the past 7 days, except in specific circumstances for non-lymphoma conditions (confirm with trial site)
• People who received CAR-T cell therapy within the past 3 months
• People who still have ongoing side effects (grade 2 or higher) from previous cancer treatment that have not stabilised (hair loss is an exception)
• People with an active, clinically significant infection rated grade 2 or higher
• People with poorly controlled diabetes, even with diabetes medication (random blood sugar of 11.1 mmol/L or above, or HbA1c of 8.5% or above)
• People with severe lung disease
• People with serious heart conditions, including significantly reduced heart pumping function, a prolonged heart rhythm measurement (QTcF), unstable chest pain, recent heart attack, heart failure, or cardiomyopathy
• People with significantly reduced kidney or liver function
• People with uncontrolled active hepatitis B, hepatitis C, syphilis (with both types of test positive), or active Epstein-Barr virus infection (confirm with trial site for specific test definitions)
• People who are known to be HIV positive
• People with a history of certain mental health conditions — including depression, bipolar disorder, obsessive-compulsive disorder, schizophrenia, suicidal thoughts or attempts, thoughts of harming others, or anxiety above grade 3 — where the investigator considers participation unsuitable
• People who need to take blood-thinning or antiplatelet medication during the study period
• People with uncontrolled high blood pressure (systolic 180 mmHg or above and/or diastolic 110 mmHg or above)
• People with serious medical conditions that carry a significant risk of major bleeding, or who have a history of major bleeding
• People currently taking medications known to affect heart rhythm in a specific way (QT prolongation or torsades de pointes)
• People who are currently taking, or who will need to take, strong inhibitors or inducers of a liver enzyme called CYP3A4, within 4 weeks before or during the study (moderate or weak inhibitors may be permitted — confirm with trial site)
• People who participated in another clinical trial and received an experimental drug within the past 4 weeks
• People who have any unstable condition that the investigator believes could put them at risk or affect their ability to follow the study requirements
• People considered unsuitable for this treatment by the investigator for any other reason

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