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:

• Adults aged 18 or older who a qualified doctor has determined are suitable for treatment with the full-dose drug combination called Pola-R-CHP, and possibly also a drug called glofitamab.
• People who have been diagnosed with a type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL) or certain closely related types, as confirmed by a tissue sample and classified under recognised medical guidelines.
• People who have not previously received treatment for DLBCL, with two exceptions: prior radiation therapy given for symptom relief (not to a specific localised area), or up to 7 days of a corticosteroid medication (such as prednisone at a specific dose).
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2).
• People who have at least one measurable area of lymphoma visible on a scan — a lymph node measuring at least 1.5 cm, or a tumour outside a lymph node measuring at least 1.0 cm.
• People whose heart is pumping efficiently, with a heart function measurement of 50% or above, confirmed by a heart scan or ultrasound.
• People who are willing and able to use highly effective contraception during treatment and for a set period after the last dose (up to 18 months for women who could become pregnant, and up to 6 months for men). Men must also agree not to donate sperm during this time. Methods such as abstinence, tubal ligation, male sterilisation, hormonal contraceptives that stop ovulation, or certain types of intrauterine devices are considered acceptable. Periodic abstinence and withdrawal are not accepted as suitable methods.
• People who are willing and able to attend all required appointments and complete all study procedures.
• People who are able to understand the study and are willing to sign a consent form before any study procedures begin (or have a legally recognised representative do so on their behalf).

Who may not be able to join:

• People who have had, or currently have, lymphoma affecting the brain or spinal cord (central nervous system lymphoma).
• People who have previously been treated with certain medicines, including any anthracycline chemotherapy, rituximab, or a type of treatment called a CD3-targeted bispecific antibody.
• People who have had another cancer (or are currently being treated for one), unless it was a minor skin cancer, early-stage cervical cancer, or a cancer that has been in remission for at least 2 years and is not expected to affect life expectancy within 5 years. People receiving ongoing hormonal therapy for early breast or prostate cancer may still be considered (confirm with trial site).
• People with serious heart conditions, such as severe heart failure (New York Heart Association Class III or IV), a heart attack within the past 6 months, unstable irregular heartbeat, or unstable chest pain. People with well-controlled, symptom-free atrial fibrillation may still be considered.
• People with significant, poorly controlled other serious illnesses that could interfere with the study, such as poorly controlled diabetes, serious lung conditions, or known autoimmune diseases.
• People with a known or suspected history of a serious immune system condition called haemophagocytic lymphohistiocytosis (HLH).
• People with a history of illicit drug or alcohol misuse within the 12 months before screening, as assessed by the investigator.
• People with a known active infection of any kind (bacterial, viral, fungal, or other), or a recent serious infection requiring hospitalisation or intravenous antibiotics within the past 4 weeks. People who are HIV-positive may still be considered if they are stable on HIV treatment, have an adequate immune cell count, and have an undetectable level of the virus.
• People with a known severe allergy or serious reaction to any of the study drugs (glofitamab or the components of Pola-R-CHP), including severe allergic reactions to any antibody-based treatment.
• People with a known severe allergy to certain biological materials used in the production of rituximab, including murine (mouse) proteins or Chinese Hamster Ovary cell proteins.
• People with an active brain or nervous system condition such as stroke, epilepsy, brain blood vessel inflammation, or a degenerative nerve disease. People with a past history of stroke who have had no stroke or mini-stroke in the past 2 years and have no remaining neurological effects may still be considered.
• People with an active autoimmune disease that is not well controlled by treatment. Some autoimmune conditions may still allow participation (such as well-controlled thyroid disease on stable medication, controlled Type 1 diabetes on insulin, or autoimmune skin conditions), but certain serious autoimmune diseases — including autoimmune hepatitis, lupus, inflammatory bowel disease, multiple sclerosis, and others — will generally prevent participation. Some autoimmune conditions may be acceptable if no systemic treatment has been needed in the past 12 months (confirm with trial site).
• People who have had a major surgical procedure within 4 weeks before starting the study drug, or who have not fully recovered from surgery.
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before starting treatment, or who expect to need one during the study. Live vaccines are not permitted during the study until the immune system has recovered.
• People who are currently using certain prohibited treatments, including other experimental drugs, certain biological therapies, immunotherapy, chemotherapy other than what is specified in the study, certain hormone therapies, or ongoing steroid use (inhaled, topical, or oral).
• People who test positive for active hepatitis B virus infection. People with a past (but not active) hepatitis B infection may still be considered under specific conditions, including regular DNA monitoring (confirm with trial site).
• People who test positive for hepatitis C antibodies, unless a follow-up test confirms the virus is no longer present in the blood.
• People with a very low white blood cell count (specifically neutrophils below 1.0 x10⁹/L), unless this is caused by the lymphoma affecting the bone marrow.
• People with a low haemoglobin (red blood cell protein) level of 9 g/dL or below.
• People with a very low platelet count (below 50 x10⁹/L), unless this is caused by the lymphoma affecting the bone marrow.
• People with significantly elevated liver function test results or high bilirubin levels beyond specified limits, unless explained by the lymphoma affecting the liver (confirm with trial site for specific thresholds).
• People with significantly reduced kidney function (creatinine clearance below 30 mL/min).
• People with significantly abnormal blood clotting results, in the absence of blood-thinning medication (confirm with trial site for specific values).
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within a specified period after the final dose of study treatment. A negative pregnancy test within 7 days before starting treatment is required for women who could become pregnant.
• People who are currently participating in another treatment-based clinical trial.
• People with any other medical condition, test result, or physical finding that the trial team considers would make participation unsafe or affect the study results.
• People with more than mild nerve damage affecting the hands or feet (Grade 2 or above peripheral neuropathy), or a specific inherited nerve condition called Charcot-Marie-Tooth disease.
• People with a known history of a rare brain condition called progressive multifocal leukoencephalopathy (PML).
• People who have tested positive for COVID-19 (SARS-CoV-2) within 7 days before enrolling in the study (a rapid antigen test result is acceptable).
• People with a known or suspected ongoing active Epstein-Barr virus (EBV) infection.

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