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 are 18 years of age or older at the time of signing the consent form.
• People whose doctor estimates they have a life expectancy of at least 12 weeks.
• People who are reasonably physically active and able to care for themselves (as measured by a standard medical scoring system).
• People who have been previously diagnosed with Mantle Cell Lymphoma (MCL) that came back or did not respond to at least one prior treatment that included two specific types of therapy: an anti-CD20 antibody treatment and a chemotherapy containing an alkylating agent.
• People who have at least one measurable area of disease visible on a PET/CT scan (lymph node larger than 1.5 cm, or a non-lymph node site larger than 1.0 cm that shows up on the scan).
• People who have leftover tissue samples from a previous biopsy available for testing to confirm the diagnosis.
• People whose blood counts and organ function fall within acceptable ranges, specifically: haemoglobin at least 9 g/dL, neutrophil count at least 1.0 x 10⁹/L, and platelets at least 75 x 10⁹/L (or at least 50 x 10⁹/L if the bone marrow is affected by the lymphoma) — all measured within 7 days before screening.
• People whose liver function blood test results are within acceptable limits (bilirubin, AST, and ALT levels below certain thresholds, with slightly higher limits allowed for people with a condition called Gilbert syndrome or where the lymphoma is affecting the liver).
• People whose kidneys are working well enough, as measured by a kidney function calculation (creatinine clearance of at least 50 mL/min).
• People whose blood clotting test results (aPTT/PTT and PT/INR) are within acceptable ranges.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, and must agree to use highly effective contraception for specific periods after each study drug (up to 18 months depending on the drug), and must not donate eggs for at least 1 month after the last dose of pirtobrutinib.
• Men must agree to use contraception or abstain during treatment and for specific periods afterwards (up to 3 months depending on the drug), and must not donate sperm during these periods.
• People who are willing and able to give informed consent and follow the study requirements.
• People who have recovered from side effects of prior treatments to a mild level (Grade 1 or lower), except for hair loss or mild nerve-related symptoms (Grade 2 peripheral neuropathy).
• People who are able to swallow oral (tablet or capsule) medications.
• People who test positive for a past hepatitis B exposure (anti-HBc positive) but do not have active hepatitis B surface antigen must have a negative hepatitis B PCR test before starting treatment, and must receive preventive antiviral medication for the duration of the study and for at least 6 months afterwards.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on hepatitis C treatment with an undetectable viral load.

Who may not be able to join:

• People who are pregnant, planning to become pregnant during the study or within specified time periods after each study drug ends (up to 18 months depending on the drug), or who are currently chest-feeding (breastfeeding should be avoided for at least 1 week after stopping pirtobrutinib).
• People who had a serious bleeding event or a severe heart rhythm problem (Grade 3 or higher) while previously taking a type of drug called a BTK inhibitor.
• People who stopped taking a covalent BTK inhibitor because their cancer progressed or came back on that treatment (those who stopped due to side effects may still be considered — confirm with trial site).
• People who have previously received a CD20/CD3-directed bispecific antibody treatment for lymphoma.
• People who received a donor stem cell transplant (allogeneic SCT) within the past 6 months, are still taking immunosuppressive medications, or have active graft-versus-host disease.
• People who have had a solid organ transplant (such as a kidney or liver transplant).
• People who have received radiation therapy within 2 weeks before starting the study (or within 4 weeks if there is no other measurable lesion outside the treated area).
• People who received their own stem cell transplant (autologous SCT) within the past 90 days.
• People who received CAR T-cell therapy within the past 60 days, or who still have ongoing side effects of Grade 2 or higher from that therapy.
• People who received monoclonal antibody or antibody-drug conjugate treatments within the past 4 weeks.
• People who received radioimmunotherapy within the past 12 weeks.
• People taking immune-suppressing medications (such as methotrexate, azathioprine, or anti-TNF agents) within 2 weeks or five half-lives (whichever is shorter) before starting the study — certain low-dose steroids and inhaled steroids are permitted (confirm with trial site).
• People who received a live vaccine within the past 4 weeks, or who are expected to need one during the study or within 5 months of the final dose.
• People who have active lymphoma in the brain or spinal fluid.
• People with a current or past serious brain or nervous system condition such as stroke (within the past 2 years or with lasting effects), epilepsy, brain blood vessel disease, or a degenerative brain condition. People with a stroke history more than 2 years ago and no remaining neurological problems may be considered (confirm with trial site).
• People with another active cancer, unless it is in remission and their life expectancy is greater than 2 years.
• People who had a major surgery (under general anaesthesia) within the past 30 days.
• People with a history of severe allergic or anaphylactic reactions to humanised or mouse-based antibody therapies.
• People with a history of certain autoimmune diseases (such as lupus, rheumatoid arthritis, multiple sclerosis, autoimmune hepatitis, and others). Some conditions such as well-controlled thyroid disease, well-controlled type 1 diabetes, or immune-related low blood counts may still be eligible — confirm with trial site.
• People with significant heart disease, including advanced heart failure, a heart attack within the past 6 months, unstable heart rhythm, unstable angina or acute coronary syndrome within the past 2 months, or a heart pumping function of 40% or less measured in the past 12 months.
• People with a specific abnormality on their heart tracing (ECG) called a prolonged QTc interval (above 470 milliseconds, using Fridericia's correction).
• People with serious lung disease that is expected to interfere with treatment.
• People with a confirmed history of a serious brain infection called progressive multifocal leukoencephalopathy (PML).
• People with a known active infection of any kind (including COVID-19, EBV, CMV, hepatitis B or C, bacterial, fungal, or other infections), or who required hospitalisation or intravenous antibiotics for an infection within the past 4 weeks.
• People who need ongoing blood-thinning treatment with warfarin or a related vitamin K antagonist medication.
• People with a known or suspected history of a serious immune system condition called haemophagocytic lymphohistiocytosis (HLH).
• People who are known to be HIV positive, or who test positive for HIV at screening.
• People with a history of a bleeding disorder.
• People with a condition that significantly affects the body's ability to absorb medications taken by mouth.
• People with a known allergy to pirtobrutinib or to any of the other study medications.
• People who need ongoing treatment with strong medications that significantly affect how the body processes a liver enzyme called CYP3A — a washout period of at least 5 half-lives of that medication is required before starting the study (confirm with trial site).

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