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 confirmed by laboratory testing to have relapsed B-cell central nervous system lymphoma — either originating in the brain/spinal cord, or spreading there from elsewhere in the body (with no active disease outside the brain/spinal cord).
• People aged 18 or older, of any gender.
• People whose ability to carry out daily activities meets a minimum threshold, as measured by a standardised scale called the Karnofsky Performance Status (KPS score of 40 or above).
• People who are not suitable candidates for a standard chemotherapy drug called methotrexate — for example, due to frailty, kidney problems, mouth sores, fluid build-up in body cavities, or personal choice to decline that treatment.
• People whose treating doctor judges them to have a life expectancy of more than 3 months.
• People who have brain lesions of a certain size visible on MRI scan, or who have lymphoma affecting the fluid around the brain and spine, with appropriate spinal fluid testing completed within 14 days before joining.
• People whose side effects from any previous cancer treatment have mostly resolved to a mild or baseline level.
• People whose blood counts, liver function, kidney function, and blood clotting results fall within acceptable ranges, without needing recent support such as transfusions or growth factor injections in the 14 days before consenting.
• People of reproductive age (both women who could become pregnant and men who could father a child) who agree to use effective contraception throughout the study and for 3 months after treatment ends, and male participants who agree not to donate sperm during this period.
• People who are willing and able to have multiple MRI or CT scans, and who are expected to be able to undergo a lumbar puncture (spinal tap).
• People who are able to swallow oral (by mouth) medications without difficulty.
• People (or their legal guardians) who give voluntary written consent to participate.

Who may not be able to join:

• People with lymphoma that has spread outside the brain or spinal cord and requires treatment targeting the whole body.
• People who have received chemotherapy, radiation, immunotherapy, or antibody-based cancer treatments within 4 weeks before the first dose (or within 5 half-lives of the drug); or small molecule targeted drugs or certain traditional medicines within 2 weeks; or antibody-drug conjugate treatments within 10 weeks.
• People who have received any vaccine (such as COVID-19, flu, pneumonia, shingles, hepatitis B, or others) within 4 weeks before starting treatment.
• People currently enrolled in another interventional clinical trial, or whose last dose in a previous trial was fewer than 4 weeks ago.
• People with a history of severe immune-related side effects (Grade 3 or above) from previous treatment with thiotepa, PD-1 inhibitors, or BTK inhibitors (other prior use of these drugs requires individual assessment by the investigator).
• People who have had active bleeding in the 4 weeks before starting treatment, who need ongoing blood-thinning medication (such as warfarin), or who have conditions associated with a high risk of bleeding, as judged by the investigator.
• People who need to take certain medications that significantly affect how the body processes a specific group of drugs (moderate or strong CYP3A4/5 inhibitors or inducers) within 2 weeks before or during the study (confirm with trial site).
• People who have another active cancer that requires treatment at the same time.
• People with serious or uncontrolled heart conditions, including: severe heart failure, heart attack, unstable chest pain, certain abnormal heart rhythms, or low heart pumping function within the past 6 months; certain inherited or structural heart muscle diseases; significant abnormalities in heart electrical activity (prolonged QTc interval or certain types of heart block); a type of irregular heart rhythm called atrial fibrillation of a certain severity; or poorly controlled high blood pressure that the investigator considers unsuitable for participation.
• People with an active, uncontrolled infection that requires intravenous antibiotic, antifungal, or antiviral treatment.
• People with active hepatitis B, active hepatitis C, or active syphilis. People who test positive for hepatitis B or C markers during screening must have further blood tests showing the virus level is below a specified threshold before the trial site can consider them for enrollment. People with well-controlled or cured hepatitis may be considered.
• People with a known history of HIV or AIDS.
• People with significant stomach or bowel problems that would affect the ability to take, absorb, or keep down oral medications (such as an inability to swallow, chronic severe diarrhoea, bowel obstruction), or who have had their entire stomach removed.
• People who have had an autologous stem cell transplant within the past 3 months, or an organ or donor stem cell transplant within the past 6 months.
• People who are pregnant or breastfeeding.
• People who have had a stroke or bleeding in the brain within 6 months before the first dose (excluding certain post-surgical effects — confirm with trial site).
• People with a history of or current significant lung scarring or inflammation conditions, such as pulmonary fibrosis or interstitial lung disease, if the investigator considers this unsuitable.
• People whom the investigator considers unsuitable due to significant kidney, nerve, mental health, liver, or hormonal conditions, or for any other medical reason.
• People with active autoimmune diseases or a relevant history of them — for example, certain neurological autoimmune conditions, multiple sclerosis, lupus, inflammatory bowel disease, certain serious skin conditions, or antiphospholipid syndrome. Some milder autoimmune conditions (such as vitiligo, eczema, well-controlled type 1 diabetes, or certain thyroid conditions) may still be eligible, and some others such as rheumatoid arthritis or psoriasis treated only with creams will be assessed individually by the investigator.
• People who have had major surgery within 28 days before the first dose.

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