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 have signed a written consent form agreeing to take part in the trial
• People aged over 18 years
• People who understand and speak one of the official languages of the country where the trial is being conducted
• People whose lymphoma has been confirmed by tissue testing (biopsy) as a specific type of aggressive B-cell non-Hodgkin lymphoma — including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), or follicular lymphoma Grade 3B — that has come back after treatment; people whose slow-growing (indolent) lymphoma transformed into an aggressive type and was previously treated with a specific chemotherapy combination (R-CHOP or similar) after that transformation may also meet this criterion (confirm with trial site)
• People whose lymphoma shows up as active on a PET scan (a type of imaging that detects cancer activity)
• People who have previously received a standard first-line treatment that included both an anti-CD20 antibody medication (such as rituximab or obinutuzumab) and a CHOP or CHOP-like chemotherapy regimen at full doses
• People whose lymphoma went into complete remission after first-line treatment, then came back (confirmed by PET scan and biopsy) at least 12 months but no more than 5 years after finishing that treatment
• People whom a specialist CAR-T doctor has assessed as suitable for CAR-T cell therapy, and who also meet a set of health and blood test criteria, including: a reasonable level of physical functioning, adequate access to a vein for a blood collection procedure, sufficient levels of certain blood cells, adequate kidney and liver function, heart pumping function of at least 45%, and blood oxygen levels of at least 92% while breathing normal air (confirm specific values with trial site)
• Women who could become pregnant must have a negative pregnancy test before joining; women who have had surgical sterilisation or have been through menopause for at least 12 months are not required to take this test

Who may not be able to join:

• People who have received more than one prior course (line) of systemic cancer treatment
• People whose lymphoma came back less than 12 months after completing first-line treatment
• People whose lymphoma did not respond well enough to first-line treatment — for example, if the disease continued to grow during treatment, did not reduce after at least 4 treatment cycles, or still showed confirmed active disease after at least 6 cycles
• People with an indolent (slow-growing) lymphoma that was treated with R-CHOP or a similar regimen as first-line therapy and then transformed into an aggressive lymphoma that returned more than a year after finishing that treatment (confirm with trial site)
• People who have previously received any treatment that targets the CD19 protein
• People whose lymphoma has spread to the chambers of the heart
• People who need urgent treatment because the tumour is pressing on or blocking important structures such as blood vessels or the bowel
• People with a significant build-up of fluid around the lungs
• People who have had another cancer in the past 3 years (exceptions may apply for certain non-invasive skin cancers or early-stage cancers; confirm with trial site), or who are currently on ongoing treatment (maintenance therapy) for another cancer
• People with lymphoma that has spread to the brain or spinal cord (central nervous system) at the time of joining; people who had CNS lymphoma in the past but have no active disease confirmed by brain scan and spinal fluid testing may still be considered
• People with certain serious brain or nervous system conditions, including dementia, certain autoimmune diseases affecting the brain, brain swelling with confirmed structural damage, or seizure disorders requiring ongoing medication; also people who have had a stroke, mini-stroke (TIA), or a specific brain condition called PRES within the 12 months before joining
• People who have a long-term internal drain or tube in place (such as a kidney drain, urinary catheter, or bile drain); standard central venous access devices such as a Port-a-Cath or Hickman line are generally permitted
• People with a current or past hepatitis B or C infection, unless the infection was successfully treated and the virus is no longer detectable on testing
• People who are HIV positive, unless taking appropriate HIV medications with an undetectable viral load and a CD4 cell count above 200 cells/uL
• People with an active, uncontrolled infection (fungal, bacterial, viral, or other) at the time of the blood collection procedure or treatment
• People who have had serious heart problems in the past 12 months, including severe heart failure, a heart attack, heart procedure such as angioplasty or stenting, unstable chest pain, or other significant heart disease
• People with a primary immune deficiency condition
• People who have required systemic immune-suppressing medications or disease-modifying drugs for an autoimmune condition (such as Crohn's disease, rheumatoid arthritis, or lupus) within the past year; certain hormone replacement at normal physiological doses may be permitted (confirm with trial site)
• People with a history of certain serious lung conditions, including pulmonary fibrosis, specific types of pneumonitis (lung inflammation), or active pneumonitis seen on a chest CT scan at screening
• People who have had a severe allergic reaction to any of the medications used in this trial, including tocilizumab, aminoglycosides, cyclophosphamide, or fludarabine
• People who have received a live vaccine within 6 weeks before starting the study, or who expect to need one during the study
• People who are pregnant or breastfeeding
• People of any sex who are not willing to use contraception from the time of consent throughout treatment and for at least 12 months after the last dose of conditioning chemotherapy or the trial treatment, whichever comes later
• People who, in the investigator's judgement, are unlikely to be able to complete all required trial visits and procedures
• People who are unable to provide informed consent due to intellectual impairment, a serious medical condition, significant abnormal test results, or a psychiatric illness

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