Phase 1 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 to 80 years who have a type of B-cell non-Hodgkin Lymphoma (a blood cancer) that has come back or stopped responding to treatment.
• People diagnosed with one of these specific lymphoma types: Diffuse Large B-Cell Lymphoma (DLBCL) and related subtypes, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma, or Burkitt Lymphoma.
• People with DLBCL or related subtypes who have previously received a specific antibody treatment (rituximab or similar) combined with chemotherapy, and whose disease either did not respond to one treatment, came back within 6 months, came back after two different chemotherapy treatments (if a stem cell transplant is not suitable), or came back after a stem cell or CAR T-cell transplant.
• People with Mantle Cell Lymphoma who have previously received rituximab or a similar antibody with chemotherapy, and whose disease came back after two lines of chemotherapy, progressed on a certain type of targeted therapy (BTK inhibitor), or came back after a stem cell transplant.
• People with Marginal Zone Lymphoma or Follicular Lymphoma who have previously received rituximab or a similar antibody with chemotherapy, and whose disease came back after two lines of treatment or after a stem cell transplant.
• People with Burkitt Lymphoma who have previously received rituximab or a similar antibody with chemotherapy, and whose disease did not respond, came back within 6 months, came back after two treatments (if a stem cell transplant is not suitable), or came back after a stem cell transplant.
• People who are well enough to carry out most normal daily activities, as measured by a standard health scoring tool (confirm with trial site).
• People who are expected to live longer than 12 weeks.
• People who have been able to follow through with previous treatments as directed.
• People who are able to swallow and digest oral (tablet or capsule) medications.
• People whose blood clotting results are within an acceptable range (confirm with trial site).
• People whose previous treatment side effects have mostly resolved before starting the trial, with some exceptions allowed (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test at the start of the trial.
• Women who could become pregnant, and their partners, must agree to use highly effective contraception during the trial and for one month after the last dose.
• For the part of the trial involving a medication called pirtobrutinib: people with blood counts (white cells, platelets, and haemoglobin) and liver and kidney function within acceptable levels (confirm with trial site).
• For the CAR T-cell treatment part of the trial: people with measurable, active disease confirmed within 4 weeks before treatment begins.
• For the CAR T-cell treatment part: people with adequate heart function (with a heart pumping strength of at least 45%) and adequate lung function (blood oxygen level of at least 92% on room air).
• For the CAR T-cell treatment part: people without signs of lymphoma affecting the brain or spinal fluid (unless prior brain involvement was treated successfully more than 4 weeks before joining, with remission confirmed within 8 weeks of planned CAR T-cell treatment).
• People who have previously had CAR T-cell therapy targeting CD19 or CD20 must have a biopsy after that treatment confirming that the cancer cells still carry enough of the CD19 or CD20 markers.
• People who do not have reproductive potential (for example, post-menopausal women or men with documented absence of sperm) are eligible without needing to use contraception.

Who may not be able to join:

• Women who are pregnant, planning to become pregnant during the trial or within one month of the last dose, currently breastfeeding, or planning to breastfeed during the trial or within one week of the last dose.
• People with a currently active hepatitis B or hepatitis C infection (confirm with trial site for specific testing requirements).
• People with a currently active cytomegalovirus (CMV) infection (a common virus).
• People with a significant autoimmune disease (where the immune system attacks the body) that is active and uncontrolled, and requires high-dose steroid treatment.
• People who still have significant side effects (grade 3 or higher) from previous cancer treatments, unless those effects are considered to be caused by the underlying disease.
• People currently taking part in another clinical treatment trial or using another experimental treatment.
• People who refuse to participate in long-term follow-up monitoring after the trial.
• People whose lymphoma has actively spread to the brain or spinal fluid at the time of joining (with some exceptions for previously treated and resolved CNS disease — confirm with trial site).
• People who received an allogeneic (donor) stem cell transplant less than 100 days ago, still have transplant-related immune complications (graft-versus-host disease), or are still on immune-suppressing medications.
• People who received donor CAR T-cell therapy less than 100 days ago.
• People who received their own (autologous) CAR T-cell therapy targeting CD19 or CD20 less than 100 days ago, or who still have more than 5% of those CAR T-cells remaining in their blood.
• People who received anti-CD20 antibody treatment within 4 weeks of the planned cell infusion.
• People who received anti-CD19 antibody treatment within 4 weeks of the planned cell infusion.
• People who received certain chemotherapy within 14 days, or steroid treatment within 7 days, before the cell collection procedure.
• People who take other oral chemotherapy or antibody treatments after starting pirtobrutinib (with limited exceptions for steroids or palliative single-site radiation — confirm with trial site).
• People who have had a solid organ transplant (such as a kidney or liver transplant) and then developed a high-grade lymphoma or leukaemia.
• People with another active cancer, with some limited exceptions (confirm with trial site).
• People who experienced a serious bleeding event or a severe heart rhythm problem while previously taking a BTK inhibitor medication.
• People who have had a stroke or bleeding in the brain within the past 6 months.
• People with significant heart problems, including a heart attack within the past 6 months, severe heart failure, unstable chest pain, or an abnormal heart electrical reading (confirm with trial site).
• People with a medical condition that significantly affects the body's ability to absorb medications taken by mouth.
• People who require blood-thinning treatment with warfarin or a similar vitamin K-blocking medication.
• People who had surgery within 4 weeks before joining the trial.
• People who received a live vaccine within 28 days before joining the trial.
• People with a known allergy to any ingredient in the pirtobrutinib medication.
• People who are trying to conceive, donate sperm, or undergo IVF while enrolled in the trial.

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