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 years or older
• People who have a confirmed diagnosis of Mantle Cell Lymphoma (MCL), diagnosed according to recognised international medical guidelines
• People who have at least one area of measurable disease that has not previously been treated with radiation, where the affected lymph node measures at least 1.5cm
• People whose doctor estimates their life expectancy to be at least 18 weeks
• People who have previously been treated with a type of drug called a BTK inhibitor (either alone or combined with other treatments), and whose lymphoma either came back or got worse after that treatment, or did not respond well enough within 12 weeks
• People whose side effects from previous treatments have mostly resolved to a mild level (with the exception of hair loss, nerve-related symptoms in the hands or feet, or low lymphocyte counts)
• People with a general physical fitness score rated 0, 1, or 2 on a standard medical scale (meaning fully active to capable of some self-care)
• People who have completed previous radiation or other cancer treatments at least a minimum number of days before starting this trial (the required waiting period depends on the type of treatment previously received — confirm with trial site)
• People who are able to swallow and digest oral (tablet/capsule) medications
• People who are willing and able to give signed informed consent and follow the trial requirements
• People of reproductive potential who are willing to use reliable contraception during treatment and for six months after the last dose
• Women who could become pregnant must have a negative blood pregnancy test within seven days of joining the trial
• People whose blood clotting levels are within an acceptable range (or where any abnormality can be explained by other known medical factors)
• People whose liver function blood test results are within acceptable limits
• People whose kidney function meets the minimum level required
• People whose blood counts (red blood cells, white blood cells, and platelets) meet the minimum levels required (some support such as transfusions may be permitted — confirm with trial site)
• People for whom stored tissue samples from a previous biopsy are available for review, or where this has been discussed and agreed with the lead investigator

Who may not be able to join:

• People who are unable to attend or stay in hospital when required by the trial
• People enrolling in the safety group of the trial who have had a donor stem cell transplant within the past 12 months, or who have ongoing graft-versus-host disease or are on immune-suppressing medication
• People who have had a stem cell transplant using their own cells, or a CAR-T cell therapy, within the past 6 weeks
• People whose MCL has spread to the brain or central nervous system and is currently active
• People who have previously been treated with pirtobrutinib, or whose lymphoma has been shown not to respond to a specific type of antibody treatment called a CD20xCD3 bispecific antibody
• People with a known severe allergic reaction to any of the ingredients in the trial drugs (pirtobrutinib, glofitamab, tocilizumab, or obinutuzumab)
• People who have had a stroke or bleeding in the brain within the past six months
• People who have received a live vaccine within the past 28 days
• People who have had major surgery or a serious injury within 28 days before starting treatment, or who are expected to need major surgery during the trial
• People with significant heart problems, including recent unstable chest pain or heart attack, a weakened heart pumping function, severe heart failure, or uncontrolled heart rhythm problems
• People whose heart electrical activity (measured on an ECG) shows a prolonged reading above a certain level on multiple tests during the screening period
• People with a known HIV infection
• People with an active Hepatitis B or Hepatitis C infection that has not been adequately treated or cleared (confirm with trial site for specific testing requirements)
• People with a known active CMV (cytomegalovirus) infection
• People who are pregnant, breastfeeding, or planning to breastfeed during the trial or within 6 months of the last dose
• People with a medical condition that significantly affects the body's ability to absorb medications through the digestive system
• People with other serious uncontrolled medical conditions, including active infections, that the investigator considers may pose a risk during participation
• People with active uncontrolled immune-related blood disorders (where new or increased treatment was needed in the 4 weeks before joining), unless caused by the MCL itself
• People with a second active cancer, unless it is in remission and life expectancy is greater than 2 years
• People currently taking certain medications that strongly interact with the way the trial drug is processed by the body (confirm specific medications with the trial site)
• People who require blood-thinning treatment with warfarin or similar vitamin K antagonist medications

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