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:

General requirements for all groups:

• People whose overall physical health and ability to carry out daily activities meets a minimum level, as assessed using standard medical scoring tools appropriate for their age.
• People whose organs (such as liver and kidneys) and bone marrow are functioning at an adequate level.

Group 1 (Module 1, Cohort 1) — for people with relapsed or refractory classical Hodgkin Lymphoma (cHL):

• In the dose-finding phase: people aged 18 or older at the time of signing the consent form; in the later phase, people aged 12 or older who weigh at least 40 kg.
• People with a confirmed diagnosis of classical Hodgkin Lymphoma (a specific type of blood cancer), confirmed by laboratory tissue testing according to recognised medical standards.
• People who have already received at least two different treatment regimens for cHL, including at least two cycles each of brentuximab vedotin (BV) and an anti-PD1 therapy, and whose disease has returned or is not responding to treatment.
• People who are able to provide a preserved tumour tissue sample taken before the trial starts.
• People who have at least one area of lymphoma that can be measured on a scan or detected by a specific type of imaging (PET scan), meeting minimum size requirements.

Group 2 (Module 1, Cohort 2) — for older people with cHL after first-line treatment:

• People aged 50 or older at the time of joining the study.
• People with a confirmed diagnosis of classical Hodgkin Lymphoma based on standard medical criteria.
• People whose disease is classified as advanced stage (Stage III or IV) using a standard staging system.
• People who have previously completed at least four cycles of a standard first-line chemotherapy combination (such as A-AVD, N-AVD, AVD, or ABVD) and whose disease responded at least partially to that treatment.
• People who are able to provide a preserved tumour tissue sample taken before the trial starts.

Group 3 (Module 1, Cohort 3) — for people with certain types of T-cell lymphoma:

• People aged 18 or older at the time of signing the consent form.
• People with a confirmed diagnosis of one of the following T-cell lymphoma types: PTCL NOS, systemic ALCL, or AITL, confirmed by laboratory testing according to recognised medical standards.
• People who have already received at least one prior treatment for their T-cell lymphoma and have no remaining treatment options known to provide a meaningful benefit; people with ALCL must have previously received brentuximab vedotin (BV).
• People who are able to provide a preserved tumour tissue sample before the trial starts, and ideally also a tissue sample taken during treatment if the tumour is safely accessible for biopsy.
• People who have at least one area of lymphoma that can be measured on a scan or detected by a specific type of imaging (PET scan), meeting minimum size requirements.

Group 4 (Module 2, Cohort 1) — for people with relapsed or refractory cHL:

• People aged 18 or older at the time of signing the consent form.
• People with a confirmed diagnosis of classical Hodgkin Lymphoma based on standard medical criteria.
• People who have at least one area of lymphoma that can be measured on a scan or detected by a specific type of imaging (PET scan), meeting minimum size requirements.
• People who have received at least one prior treatment for cHL and whose disease has returned or is not responding to treatment.
• People who are able to provide a preserved tumour tissue sample taken before the trial starts.

Who may not be able to join:

General exclusions applying to all groups:

• People with significant abnormal blood test results or a serious medical condition that is not well controlled.
• People whose lymphoma has spread to the brain or spinal cord, or whose spinal cord is being compressed.
• People with a currently active hepatitis B or hepatitis C infection detected through blood tests.
• People who have tested positive for HIV.
• People with active digestive tract problems or other conditions that would prevent them from taking oral (by mouth) medication.
• People with certain heart rhythm or electrical abnormalities detected on a heart tracing (ECG), including a specific measurement (QTcF interval) that is too long, or other factors that increase the risk of dangerous heart rhythm problems.
• People who have had any of the following heart or blood vessel procedures or events within the six months before the first dose: heart bypass surgery; a procedure to open blocked heart arteries or a heart valve repair or replacement; placement of a blood vessel stent (except in a vein); a heart attack or acute coronary event; unstable or poorly controlled chest pain (angina); dangerous heart rhythm problems requiring ongoing treatment; uncontrolled irregular heart rhythm (atrial fibrillation); a stroke or bleeding in the brain, including mini-strokes; or a serious blood clot in a vein or artery that has not been adequately treated for at least three months.
• People with serious disease affecting the heart valves.
• People with moderate to severe heart failure (Grade II to IV).
• People with a current or past diagnosis of cardiomyopathy (a disease of the heart muscle).
• People with high blood pressure that is not well controlled.
• People who have had significant coughing up of blood or serious bleeding within four weeks before the first dose of the study treatment.
• People who still have side effects rated above a mild level from previous cancer treatments (with some specific exceptions such as nerve tingling, hair loss, skin colour changes, or hormone-related conditions managed with replacement therapy).
• People with a history of another separate primary cancer (confirm with trial site for specific details).
• People who have recently received certain cancer treatments, including: anti-lymphoma therapy within 21 days; radiation therapy within 28 days; a donor stem cell transplant within 180 days; a personal stem cell transplant or cell-based therapy within 60 days; or any prior treatment with MAT2A or PRMT5 inhibitor drugs.
• People who require ongoing treatment with immune-suppressing medications, including regular steroid medicines.

Additional exclusions for Group 4 (Module 2, Cohort 1) only:

• People with a confirmed history of lung inflammation (interstitial lung disease), medication-caused lung inflammation, or radiation-related lung inflammation that required steroid treatment, or any currently active lung inflammation.
• People who experienced a serious (Grade 3 or higher) immune-related side effect while on a previous checkpoint inhibitor therapy, or who still have an unresolved moderate or worse immune-related side effect from prior treatment.
• People with a history of immune-related inflammation of the heart muscle or the lining around the heart.
• People who had to permanently stop a previous immunotherapy due to side effects.
• People with an active or previously confirmed autoimmune or inflammatory condition.
• People whose lymphoma did not respond to a previous checkpoint inhibitor treatment received within the 12 weeks before joining the study.
• People whose treating doctor considers them suitable candidates for a stem cell transplant (either from a donor or using their own cells).
• People who received a donor stem cell transplant within five years before the first dose, or who have active graft-versus-host disease (a complication from a previous transplant).
• People with a known allergy or sensitivity to pembrolizumab or any of its ingredients.

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