Phase 3 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 diagnosed with certain types of mature B-cell non-Hodgkin lymphoma (B-NHL), specifically including Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma, primary mediastinal large B-cell lymphoma, or related types, confirmed by tissue biopsy at first diagnosis.
• People whose lymphoma has come back (relapsed) for the first time, has come back more than once, or has not responded to previous treatment (refractory disease) — confirmed by scans and/or biopsy.
• People whose lymphoma came back more than two years after their last treatment, provided a new biopsy has been performed.
• People whose disease is measurable, meaning there is at least one tumour that can be measured on scans, or disease present in the bone marrow or central nervous system (CNS) that meets specific criteria (confirm with trial site for CNS-only disease).
• People aged from birth up to and including 25 years old at the time of joining the trial.
• People with a performance status of 50 or above on the Karnofsky or Lansky scale, which means they are able to carry out some daily activities despite their illness.
• People with a life expectancy of at least 8 weeks.
• People with adequate bone marrow function, based on blood test results meeting specific thresholds for platelets and neutrophils (different thresholds may apply depending on whether bone marrow is involved — confirm with trial site).
• People with adequate liver function, based on liver enzyme and bilirubin levels within acceptable ranges on blood tests.
• Female patients who could become pregnant must have a negative pregnancy test within 7 days before joining the trial.
• People of reproductive potential who agree to use effective contraception during treatment and for 12 months after treatment ends.
• People (or their parents or legal guardians) who have given written informed consent to participate.

For Treatment Arm I only, people must also meet these criteria:

• Male patients of reproductive potential who agree not to donate sperm during treatment and for 6 months after treatment ends.
• People with adequate kidney function, with a creatinine clearance greater than 45 ml/min (measured or estimated using an accepted formula).
• People with bone marrow involvement or a condition called splenic sequestration must still meet specific (lower) blood count thresholds, including platelet count, haemoglobin, and neutrophil levels (confirm with trial site).
• People who have previously received CAR T-cell therapy or other cellular therapies more than 28 days before joining, provided they have recovered from any serious side effects and still have measurable disease.

For Treatment Arm II only, people must also meet these criteria:

• People with adequate kidney function, confirmed by a directly measured kidney filtration rate (GFR) greater than 60 ml/min/1.73m², not just an estimate.
• People with bone marrow involvement or splenic sequestration are not required to meet the standard bone marrow function criteria for this arm.

Who may not be able to join:

• People diagnosed with B-cell Acute Lymphoblastic Leukaemia (B-ALL) or B-cell Lymphoblastic Lymphoma (B-LBL).
• People who have had a donor (allogeneic) stem cell transplant within the past 90 days, or their own (autologous) stem cell transplant within the past 45 days.
• People who have experienced graft versus host disease requiring whole-body (systemic) treatment or immune-suppressing medication within the past 28 days.
• People who have received an experimental treatment within the past 14 days.
• People who have received radiation to the brain and spine within the past 28 days, or any other type of radiation within the past 14 days.
• People who are still experiencing ongoing serious side effects from their most recent lymphoma treatment.
• People with a known DNA repair disorder or a known primary immune deficiency condition.
• People who are currently pregnant or breastfeeding.
• People who are unable to attend regular follow-up appointments due to psychological, social, geographical, or other circumstances.
• People for whom not following the treatment or trial procedures as required is expected to be a concern.
• People with an uncontrolled infection; severe infections such as sepsis or pneumonia must be under control before joining.
• People known to be HIV positive.
• People who are carriers of Hepatitis B, have a history of Hepatitis B infection, or have certain positive Hepatitis B blood test results (specific combinations depend on vaccination status — confirm with trial site).
• People who have received a live vaccine within 28 days before joining the trial.
• People with a known serious allergic reaction to any of the treatments or their ingredients used in this trial.

For Treatment Arm I only, people may not be able to join if they:

• Have disease only in the central nervous system (CNS-only disease).
• Have received CAR T-cell therapy or other cellular therapies within the past 28 days.
• Have reduced heart function, a significant fluid collection around the heart, or clinically significant irregular heart rhythms, based on heart scan results.
• Have disease confirmed to be CD20-negative at the time of first diagnosis.
• Have had a seizure within the last 12 months.
• Have previously been treated with a type of therapy called CD20 x CD3 bispecific therapy.
• Have a known serious allergy to both allopurinol and rasburicase (medications used to manage a condition called tumour lysis syndrome).

For Treatment Arm II only, people may not be able to join if they:

• Have received CAR T-cell therapy or other cellular therapies within the past 42 days.
• Have a significant build-up of fluid in the body cavities (such as fluid in the abdomen requiring drainage, or fluid around the lungs causing breathing difficulties), graded as clinically significant (Grade 2 or above).
• Have received steroid treatment for more than 7 days in total during the 14 days before joining the trial.

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