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 given written informed consent (or whose legal representative has done so) to take part in the trial
• People who are willing to provide a tissue sample from a tumor biopsy before starting treatment (exceptions may be possible with approval from the lead researcher)
• People aged 18 years or older
• People whose general physical functioning is rated at a level that allows for at least some self-care (an ECOG score of 2 or below — confirm with trial site what this means for a specific situation)
• People who have been formally diagnosed with mantle cell lymphoma, confirmed by a laboratory tissue examination, according to World Health Organization standards
• People whose mantle cell lymphoma has come back or stopped responding to treatment after at least one previous course of treatment, with the relapse confirmed by laboratory review
• People whose lymphoma tumor tests positive for a protein called CD20, based on laboratory testing after the most recent treatment
• People whose disease is currently active and requires treatment, as determined by their treating doctor
• People whose disease can be measured on imaging scans, meeting specific size thresholds (confirm with trial site for exact details); exceptions may be possible if disease is present in bone marrow or blood without measurable disease on scans
• People who have recovered from serious side effects of previous cancer treatments (excluding hair loss), with any remaining side effects at a mild level or below
• People whose blood cell counts and organ function meet specific thresholds for neutrophils (infection-fighting white blood cells), platelets (clotting cells), haemoglobin (a measure of red blood cell function), liver function, kidney function, and blood clotting — exact values will be assessed by the trial site
• People whose heart pumping function (left ventricular ejection fraction) is at least 40%, as measured by a heart scan
• People whose blood oxygen level is at least 92% while breathing normal room air
• Women who could become pregnant must have a negative pregnancy test before joining
• Women who could become pregnant must agree to use two reliable forms of contraception, or abstain from heterosexual intercourse, during treatment and for specific periods after the last dose of each study drug (varying from 7 days to 18 months depending on the drug); they must also not donate eggs during this time
• Men who could father a child must agree to use a condom or abstain from heterosexual intercourse during treatment and for specific periods after the last dose of each study drug; they must also not donate sperm during this time

Who may not be able to join:

• People who have previously been treated with a type of therapy called a T-cell engaging bispecific antibody
• People who have received certain recent cancer treatments — including some antibody therapies within 4 weeks, certain targeted antibody-drug combinations within 4 weeks, or other chemotherapy or radiation within 2 weeks before the start of the trial
• People who have taken a type of drug called a BTK inhibitor (such as ibrutinib, acalabrutinib, zanubrutinib, or similar drugs) for more than 180 days in total before joining; people who took these drugs for 180 days or fewer may be considered, as long as their disease did not progress while they were taking them
• People who have received a type of immune cell treatment called CAR T-cell therapy within 6 months before the trial start date
• People who have previously had an allogeneic stem cell transplant (a transplant using cells from a donor)
• People who have had an autologous stem cell transplant (using their own cells) within 3 months before the trial start date
• People who have had major surgery under general anaesthesia within 30 days before the trial start date, or who have not fully recovered from surgery
• People who are currently taking high-dose steroid tablets at a level above a specified threshold, unless they meet specific exceptions (such as short-term high-dose steroids for lymphoma symptoms, or low-dose steroids for other medical reasons)
• People who have taken certain immune-suppressing medications within 2 weeks or within five half-lives of those drugs (whichever is shorter) before the trial start
• People who have received a live virus vaccine within 30 days before the trial start, or who plan to receive one during the trial
• People who need ongoing treatment with certain drugs that strongly affect how the body processes medications (strong CYP3A4 inhibitors or inducers — confirm with trial site for specific examples)
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant)
• People who have had a severe allergic reaction to any of the study drugs or their ingredients, including reactions to previous antibody treatments
• People who are currently enrolled in another treatment-based clinical trial
• People with a history of another cancer, unless that cancer was treated with curative intent and has shown no signs of activity for at least 2 years; certain exceptions apply for some skin cancers, early-stage cancers that were fully treated, and prostate cancer being monitored without treatment
• People with a history of certain bone marrow or blood cell conditions (such as myelodysplastic syndrome), or specific genetic changes in blood cells associated with these conditions
• People with conditions that significantly affect how the body absorbs food and medication, such as certain bowel diseases, bowel obstruction, or a history of stomach or bowel surgery that affects absorption (including some types of weight-loss surgery)
• People with currently active lymphoma involvement in the brain or spinal fluid
• People with a current or past history of certain brain or nervous system conditions, such as epilepsy, stroke (within the past 2 years or with lasting neurological effects), brain blood vessel disease, or degenerative brain conditions
• People with a known history of a rare brain infection called progressive multifocal leukoencephalopathy (PML)
• People with a known or suspected history of a serious immune system condition called hemophagocytic lymphohistiocytosis (HLH)
• People who have been diagnosed with a stomach or intestinal ulcer confirmed by a camera examination of the gut (endoscopy) within 3 months before screening
• People with known bleeding disorders, such as von Willebrand's disease or haemophilia
• People with clinically significant heart disease, including severe heart failure, heart rhythm problems causing symptoms, or a heart attack within 6 months before screening; certain types of controlled, symptom-free heart rhythm irregularities may be allowed (confirm with trial site)
• People who are unable to swallow tablets or capsules
• People with a known active infection (bacterial, viral, fungal, or other) at the time of joining, or who have had a major infection within 4 weeks before the trial start date
• People with a significant history of liver disease, including hepatitis or liver scarring (cirrhosis)
• People with suspected or latent (inactive) tuberculosis
• People with active hepatitis B or hepatitis C virus infection; people with a past hepatitis B infection may be eligible if the virus is undetectable in their blood and they agree to regular monitoring and antiviral treatment; people with a past hepatitis C infection may be eligible if current testing shows the virus is not present
• People with active HIV infection; people with HIV who have an undetectable viral level, a CD4 count above 200, and who are on effective HIV treatment may be considered
• Women who are pregnant, breastfeeding, planning to become pregnant, or who are unwilling or unable to follow the pregnancy testing and contraception requirements of the trial
• People with any other medical condition that, in the investigator's judgement, would make participation unsafe
• People who, in the investigator's opinion, may not be able to follow all trial procedures and requirements

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