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 aged 70 or older who a treating doctor has decided are not suitable for standard full-strength chemotherapy combined with immunotherapy.
• People with a general health and activity level that falls within a certain range, as assessed by their doctor using a standard scale (ECOG score of 0–2).
• People with a confirmed diagnosis of certain types of aggressive B-cell lymphoma, including DLBCL (not otherwise specified), high-grade B-cell lymphoma with specific genetic changes (MYC and BCL2 rearrangements), high-grade B-cell lymphoma (not otherwise specified), or grade 3b follicular lymphoma.
• People whose slower-growing lymphoma has transformed into a more aggressive type (histologic transformation), confirmed by a biopsy — prior treatment for the original slower-growing lymphoma is allowed, but prior treatment with a specific type of chemotherapy drug (anthracyclines) is not.
• People with a lymphoma that contains both slow-growing and large-cell features (composite or discordant lymphoma).
• People who have had little or no prior treatment for aggressive lymphoma — limited exceptions include a short course of steroids for symptoms, one cycle of anthracycline-containing chemotherapy, or a pre-treatment course with a drug called polatuzumab vedotin plus steroids (at the treating doctor's discretion).
• People whose heart is pumping at 45% or above, as measured by a heart scan (echocardiogram or MUGA).
• People whose platelet count meets a minimum level on blood tests during screening (at least 75,000/µL, or at least 30,000/µL if the low count is caused by the lymphoma affecting the bone marrow).
• People whose white blood cell (neutrophil) count meets a minimum level on blood tests during screening (at least 1,500/µL, or at least 500/µL if the low count is caused by lymphoma in the bone marrow).
• People whose kidneys are functioning above a certain level, as measured by a kidney function test (creatinine clearance above 40 mL/minute).
• People whose liver function test results fall within acceptable ranges — specific limits apply, with some exceptions allowed if the abnormality is due to a known condition (Gilbert syndrome) or lymphoma affecting the liver (confirm with trial site).
• People who, with treatment, are expected by their doctor to live for at least 12 weeks.
• People who are able to give signed informed consent and follow the study schedule.

Who may not be able to join:

• People with lymphoma that has spread to, or started in, the brain or spinal cord (central nervous system lymphoma).
• People with a type of lymphoma called primary mediastinal B-cell lymphoma.
• People currently on kidney dialysis (either peritoneal or haemodialysis).
• People with more than mild nerve damage (peripheral neuropathy above Grade 1).
• People with a heart pumping below 45%, or a significant history of serious heart conditions — including advanced heart failure (New York Heart Association Class III or IV), a heart attack within the past 6 months, unstable heart rhythm problems, or unstable chest pain (angina).
• People who have taken another experimental drug within 28 days before enrolling.
• People who have previously been treated with anthracycline chemotherapy drugs.
• People with another active cancer that the treating doctor believes could affect the ability to measure the trial's results — some exceptions may apply for certain early-stage or low-risk cancers, after discussion with the trial team.
• People who test positive for HIV, unless they have been stable on HIV treatment for at least 4 weeks, have a CD4 immune cell count of 200/µL or above, have an undetectable HIV viral load, and have not had any serious HIV-related infection in the past 12 months.
• People with active hepatitis B infection showing a positive surface antigen or detectable viral load (people who carry the hepatitis B virus but do not have active infection may be monitored and managed separately — confirm with trial site).
• People who have had a solid organ transplant (such as a kidney or liver transplant), or have developed a lymphoma related to transplantation.
• People who have previously had an allogeneic stem cell transplant (a transplant using cells from a donor).
• People with serious medical or psychiatric conditions that the treating doctor believes would make safe participation in the trial difficult — this includes significant brain or nervous system disease, active infections, or certain autoimmune conditions.
• People with significant abnormal blood test or urine test results during screening that the investigator believes would make it hard to safely evaluate their response to treatment.
• People who have been taking strong immune-suppressing medications (such as prednisone above 20 mg, azathioprine, methotrexate, thalidomide, or anti-TNF agents) within 2 weeks before the first treatment — some exceptions apply for inhaled steroids, certain low-dose medications for specific symptoms, or dexamethasone at 20 mg or less (confirm with trial site).

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