Phase 1 Lymphoma Trial, Recruiting

Written by an AI model from the 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 consent to participate (or whose legal representative has done so on their behalf).
• People who are willing to provide a tissue sample from a biopsy of a tumour, taken as part of their usual care, before starting the study treatment (exceptions may be possible with approval from the lead study doctor).
• People aged 18 or older.
• People whose general physical functioning is rated at a moderate level or better on a standard medical scale (ECOG score of 0, 1, or 2).
• People who have been confirmed through laboratory testing to have mantle cell lymphoma (MCL), a type of blood cancer, diagnosed according to recognised international medical standards, including specific protein markers on the cancer cells.
• People whose MCL has come back or stopped responding after at least one previous course of treatment for the cancer.
• People whose cancer relapse has been confirmed through a biopsy and reviewed by a specialist (exceptions may be granted by the lead study doctor).
• People who are currently being treated with a single BTK inhibitor medication (such as ibrutinib, acalabrutinib, or zanubrutinib), who previously responded to that treatment, and whose cancer is now showing signs of growing again.
• People whose cancer can be measured on imaging scans according to standard medical criteria, with tumour sites of a certain minimum size (confirm with trial site for specific measurements).
• People who have recovered from most side effects of previous cancer treatments (minor ongoing effects at a low level may be acceptable; hair loss is an exception and does not need to have resolved).
• People whose blood cell counts and organ function meet specific minimum levels as measured by blood tests, including white blood cell counts, platelet counts, liver function, and kidney function (the required levels vary depending on whether or not the cancer has spread to the bone marrow — confirm with trial site for specific values).
• People whose blood clotting measures fall within acceptable ranges (different thresholds apply depending on whether or not the person is taking blood-thinning medication — confirm with trial site).
• People whose heart pumping function is at or above 50% as measured by a heart scan.
• People whose heart's electrical activity (specifically a measure called QTc) is within an acceptable range on a heart tracing test.
• Women who could become pregnant must have a negative pregnancy test before joining.
• People of childbearing potential (both male and female) who agree to use highly effective contraception during treatment and for a set period after the last dose of each study medication (at least 90 days after the last dose of pacritinib and at least 30 days after the last dose of the BTK inhibitor — confirm with trial site for full contraception requirements, as certain methods such as oral contraceptives alone are not considered sufficient).

Who may not be able to join:

• People who have had an autologous stem cell transplant (using their own stem cells) within 3 months before the start of study treatment.
• People who have previously had an allogeneic stem cell transplant (using another person's stem cells).
• People who have previously been treated with pacritinib or any JAK2 inhibitor medication.
• People currently being treated with a medication called pirtobrutinib.
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors) within 14 days before the start of study treatment (a shorter gap may be considered with lead study doctor approval).
• People who have taken medications that increase the risk of bleeding — including blood thinners, most anti-platelet drugs (aspirin above 100 mg per day), certain anti-cancer drugs, or certain anti-inflammatory painkillers taken daily — within 14 days before the start of study treatment.
• People who have taken medications known to affect heart rhythm within 14 days before the start of study treatment (a shorter gap may be considered with lead study doctor approval).
• People taking steroid medications at a dose higher than the equivalent of 20 mg per day of prednisone, unless the use falls under specific short-term or low-dose exceptions as determined by the study team.
• People who have had a significant bleeding episode in the 3 months before the start of study treatment, unless it was caused by a specific identifiable event such as surgery or injury.
• People with known bleeding disorders such as von Willebrand's disease or haemophilia.
• People with certain factors that increase the risk of an abnormal heart rhythm, such as persistently low potassium levels that cannot be corrected, or a personal history of a condition called long QT syndrome.
• People with significant heart problems, such as symptoms of irregular heartbeat, heart failure, or a heart attack within 3 months before screening, or who have severe heart disease as classified by standard medical grading systems (people with controlled, symptom-free atrial fibrillation or flutter may still be eligible — confirm with trial site).
• People who are unable to swallow and keep down oral (tablet or capsule) medication.
• People with active digestive or metabolic conditions that could significantly affect how oral medication is absorbed by the body.
• People with active or poorly controlled bowel conditions such as Crohn's disease, inflammatory bowel disease, ongoing diarrhoea, or ongoing constipation.
• People with a known allergy or sensitivity to pacritinib or any of its ingredients, or to anti-diarrhoea medication such as loperamide.
• People with known active spread of lymphoma to the brain or spinal fluid.
• People with a known history of a serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People with another cancer whose history or treatment could interfere with assessing the safety or effectiveness of this trial's treatment.
• People with a known active infection of any type at the time of enrolment, or who have had a significant infection within 4 weeks before the start of study treatment.
• People with known active hepatitis B or hepatitis C infection (people with a past hepatitis B infection may be eligible under certain conditions — confirm with trial site).
• People with known active HIV infection (people with well-controlled HIV on appropriate treatment and with adequate immune cell levels may be eligible — confirm with trial site).
• Women who are pregnant or breastfeeding.
• People with any other medical condition that the study doctor believes would make participation unsafe.
• People who, in the study doctor's opinion, may not be able to follow all of the study's requirements and procedures.

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