Phase 2 Leukaemia 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 aged 18 or older who have been diagnosed with a specific type of blood cancer called CD19-positive non-Hodgkin lymphoma (including many subtypes such as Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Burkitt Lymphoma, Mantle Cell Lymphoma, and others listed in the trial), or a related condition called Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), confirmed by a tissue biopsy.
• People with aggressive lymphoma who have already been treated with at least 2 prior treatment courses, or whose disease came back or did not respond within 12 months of their first treatment, or who are not suitable for a stem cell transplant after at least one prior treatment — with specific timing rules varying by lymphoma subtype.
• People with indolent (slow-growing) lymphoma whose disease has returned or persisted after at least 2 prior treatment courses (single-agent rituximab or radiation do not count as a full course of treatment).
• People with Mantle Cell Lymphoma whose disease has returned or persisted after at least 1 prior treatment course (single-agent rituximab or radiation do not count).
• People with CLL or SLL whose disease has progressed or who could not tolerate at least 2 prior treatment courses, which must include specific drug types such as chemoimmunotherapy, BTK inhibitors, BCL-2 inhibitors, or PI3 Kinase inhibitors.
• People who are well enough to carry out basic daily activities, rated 0–2 on a standard medical fitness scale called the ECOG scale.
• People who have measurable cancer visible on imaging scans (PET-CT or CT), with the largest area of disease measuring at least 1.5 cm; for CLL patients without visible disease on scans, a bone marrow biopsy showing more than 5% CLL involvement may also qualify.
• People who have had previous CD19-targeted treatment must have a new tissue biopsy taken after that treatment, confirming that the cancer still has CD19 on its surface (confirm with trial site for what level is acceptable).
• People whose blood counts, liver, kidney, heart, and lung function meet certain minimum levels as tested within 14 days before enrolling (confirm with trial site for specific values).
• People with a Hepatitis B infection who have an undetectable virus level and are on suppressive medication, with no liver damage from the infection, within 14 days before enrolling.
• People with a past Hepatitis C infection who have completed treatment, have no liver damage, and have an undetectable virus level within 14 days before enrolling.
• People with HIV who are on anti-retroviral medication and have an undetectable virus level within 14 days before enrolling.
• People who are able to use acceptable contraception throughout the study; women of childbearing potential must have a negative pregnancy test within 7 days before enrolling.
• People who have adequate support from a caregiver at home, as assessed by the trial doctor.
• People who are able to understand the study and sign a consent form before any study procedures begin.

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People whose lymphoma is currently active in the brain or central nervous system (CNS); people with a past history of CNS involvement may still be considered if their disease has been in remission for at least 60 days, confirmed by specific scans and tests (confirm with trial site).
• People who have had a stem cell transplant from a donor and are currently experiencing a significant immune reaction called Graft versus Host Disease, unless it is very mild (limited to grade 1 skin involvement) and does not require immune-suppressing medication.
• People with an active infection (bacterial, fungal, or viral) that is not improving with appropriate treatment.
• People who have had a stroke or bleeding in the brain within the past 6 months, or who have a neurological condition that would make it difficult for doctors to assess for a particular side effect called neurotoxicity.
• People who have had another cancer in the past, unless they have been free of that cancer for more than 1 year — with exceptions for certain skin cancers, early-stage cervical or breast cancer in situ, or previously treated localised prostate cancer with normal test results.
• People with a primary immune deficiency or an autoimmune condition (such as Crohn's disease, rheumatoid arthritis, or lupus) who have needed immune-suppressing or disease-modifying medication within the past year.
• People who have received a live vaccine within 28 days before enrolling.
• People who have had an autologous (own cells) stem cell transplant within the past 60 days, a donor stem cell transplant within the past 90 days, or a CAR T-cell therapy within the past 180 days.
• People who have had a severe allergic reaction to any of the medications or agents used in this trial.
• People with unstable chest pain (angina), a heart attack within the past 6 months, or significant heart failure symptoms classified as Class III or IV on a standard heart health scale.
• People with any other serious health condition that, in the trial doctor's opinion, would make participation unsafe or unsuitable.

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