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:

• Adults aged 18 or older
• People who have been diagnosed with a type of blood cancer called mantle cell lymphoma (MCL), confirmed by a specific genetic marker or protein abnormality in their cancer cells
• People whose MCL has come back or stopped responding to at least one previous cancer treatment (Note: previous treatment with lenalidomide or venetoclax is allowed, as long as the cancer did not get worse while on those drugs)
• People whose doctor considers them to be in need of treatment, for example due to symptoms from the lymphoma or low blood counts
• People who have measurable disease — meaning at least one tumour or swollen lymph node of a certain size, an enlarged spleen, or a high white blood cell count (in certain cases)
• People with a general health and activity level that falls within a specific rating scale used in cancer trials (rated 0, 1, or 2 on a standard scale — meaning fully active to capable of self-care but not able to do heavy work)
• People whose recent blood tests (taken within the past 14 days) show that their blood counts, liver function, kidney function, and blood clotting levels are within acceptable ranges for the trial
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining
• People who agree to use effective contraception during treatment and for a set period after the last dose of each study drug (at least 4 weeks after lenalidomide and 3 months after tafasitamab, whichever is longer) — with specific requirements for women and men outlined by the trial
• People willing to enrol in a mandatory safety program required for one of the study drugs (REVLIMID REMS program) and follow all its requirements
• People able to take low-dose aspirin (81 mg daily) or another form of blood-thinning medication
• People who voluntarily sign a consent form within 28 days before joining
• People willing to return to the trial site for follow-up visits during the active treatment and monitoring period
• People willing to provide blood samples for research related to this trial

Who may not be able to join:

• People who are currently pregnant
• People who are breastfeeding, unless they agree not to feed their baby with their breast milk during treatment and for 3 months after the last dose of study treatment
• Men or women who could have children but are unwilling to use adequate contraception during treatment and for the required period afterwards
• People who have had a stem cell transplant using their own cells within the past 90 days
• People who have had a stem cell transplant using another person's cells (at any time)
• People who have received a specific type of immune cell therapy targeting CD19 (called CAR T-cell therapy) within the past 90 days
• People whose MCL has spread to the brain or nervous system
• People currently receiving another treatment for MCL (other than steroid medications) — or who have had recent MCL treatment where at least 14 days or 5 half-lives of the drug have not yet passed since the last dose
• People who have recently used or will need to use certain medications that can interfere with the study drugs, including blood thinners called vitamin K antagonists (within 7 days before joining), or certain drugs that affect how the body processes medications (confirm specific medications with the trial site)
• People who have consumed grapefruit, Seville oranges, or star fruit within 3 days before joining, or who plan to consume them during the trial
• People who test positive for HIV (all participants are screened before joining)
• People with active hepatitis B or hepatitis C infection requiring treatment — specific blood test results are used to determine this (confirm details with trial site)
• People with other serious ongoing illnesses that, in the treating doctor's judgement, would make participation unsafe or affect how the trial results are assessed
• People with certain serious uncontrolled heart conditions, including severe heart failure, unstable chest pain or a recent heart attack within the past 3 months, or uncontrolled irregular heartbeat (Note: people with pacemakers may still be eligible if they have no history of fainting or serious rhythm problems related to the pacemaker)
• People with lung disease that requires ongoing oxygen use, such as certain types of chronic lung disease
• People with ongoing inflammatory bowel disease (such as ulcerative colitis) that requires active treatment
• People with a condition affecting the absorption of food or medication through the gut
• People with an active infection (viral, bacterial, or fungal)
• People with a mental health condition or personal situation that would make it difficult to follow the trial requirements
• People who have had a stroke within the past 24 weeks
• People who have had a heart attack within the past 24 weeks
• People who have had major surgery within the past 28 days
• People who have received a live vaccine within the past 28 days
• People with a history of a life-threatening blood clot
• People with a bleeding condition that prevents them from safely taking low-dose aspirin or any blood-thinning medication
• People with another active cancer (other than certain minor skin cancers or early-stage cervical changes) that requires treatment or is expected to limit survival to 2 years or less (Note: people on hormonal therapy for breast or prostate cancer that has been adequately treated and is not spreading may still be eligible — confirm with trial site)
• People who are unable to swallow tablets or capsules

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