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 able to understand and are willing to sign a written consent form before any study-related activities begin.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests throughout the study.
• People who are at least 18 years old at the time of signing the consent form.
• People who have a reasonable level of physical functioning, as measured by a standard performance scale (confirm with trial site for specific score requirements).
• People who have been diagnosed with a specific type of brain lymphoma called primary DLBCL CNS lymphoma that has come back or stopped responding to treatment, confirmed through a biopsy of brain tissue, spinal fluid, or eye fluid.
• People whose brain scans (MRI) show signs that the disease has returned or is not responding to treatment.
• People whose side effects from previous treatments have mostly resolved to a mild level before starting the trial (mild nerve-related side effects may still be acceptable — confirm with trial site).
• People who are taking a low or stable dose of a steroid medication (dexamethasone or equivalent, no more than 8mg per day) that has not been increased in the two weeks before screening.
• People who are able to have an MRI scan.
• People whose blood counts and organ function meet specific minimum levels, tested within 14 days before starting treatment, including: sufficient white blood cells, platelets, and red blood cells (without recent transfusions), and adequate kidney and liver function (confirm with trial site for specific values).
• Women who could become pregnant must have a negative blood pregnancy test within 72 hours before registering for the trial.
• Women who could become pregnant and are sexually active must use a highly effective form of contraception during treatment and for 28 days after the last dose of the study drug. Male participants whose partners could become pregnant must also use contraception during treatment and for 28 days after the last dose.

Who may not be able to join:

• People who are unable to have an MRI scan of the brain.
• People who have an active cancer affecting other parts of the body (systemic disease).
• People who have another serious illness that is not well controlled.
• People who have previously been treated with a type of medication that works on the mTOR or PI3K pathways.
• People who have had another cancer requiring active treatment, unless it was a minor skin cancer, early-stage cervical cancer, superficial bladder cancer, or any other cancer from which the person has been cancer-free for at least 3 years.
• People who have received cancer treatments (including experimental therapies or radiation) within 4 weeks, or within 5 half-lives of the drug, whichever comes first, before starting the study drug.
• People who have trouble swallowing tablets or capsules, or who have a digestive condition that would prevent proper absorption of an oral medication.
• People with a known history of HIV infection, a past brain infection called PML, or any currently active serious infection (bacterial, viral, or fungal).
• People who have had a severe allergic reaction to the study drug (paxalisib) or any of its ingredients.
• People who need to take certain medications that strongly affect how the study drug is broken down in the body (strong CYP3A4 inhibitors or inducers — confirm with trial site for specific medications).
• People with certain uncontrolled medical conditions, including lung disease, severe shortness of breath, a need for oxygen therapy, or pre-existing Crohn's disease, ulcerative colitis, or another ongoing condition causing moderate or severe ongoing diarrhoea.
• People with Type 1 diabetes, people with Type 2 diabetes that is not well controlled despite oral medication, or people with Type 2 diabetes that is well controlled only with insulin. Uncontrolled diabetes is defined as having both a high HbA1c (above 9%) and high fasting blood sugar on at least two tests in the 14 days before registration (confirm with trial site).
• People with high blood pressure that remains uncontrolled despite receiving appropriate medical treatment.
• People with certain hepatitis B or C results: those who test positive for hepatitis B surface antigen or hepatitis B by a DNA PCR test will not be eligible; those with certain other hepatitis B markers may need additional testing to be considered. People who test positive for hepatitis C by a PCR test will also not be eligible (confirm with trial site for specific test requirements).
• People who are pregnant or currently breastfeeding.
• People who are already taking part in another clinical treatment trial.

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