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 1 year old up to and including 30 years old at the time of joining the trial
• People who have had their first relapse (return) of a type of blood cancer called CD19-positive B-cell acute lymphoblastic leukaemia (B-ALL), where the cancer has come back in the bone marrow, the central nervous system (brain/spinal fluid), the testes, or a combination of these sites (with some exceptions — confirm with trial site)
• People with Down syndrome whose cancer has relapsed in the bone marrow, or in the bone marrow combined with the central nervous system and/or testes (with some exceptions — confirm with trial site)
• People who are well enough to carry out normal daily activities, as measured by standard medical scoring tools (ECOG score of 0, 1, or 2)
• People who have fully recovered from the side effects of any previous cancer treatment before joining
• People who previously received certain targeted treatments (blinatumomab or CD19-directed CAR T-cell therapy) as part of their initial treatment, as long as the cancer cells still carry the CD19 marker
• People who have kidney function at or above a minimum level, based on age- and sex-specific blood test results taken within 7 days before joining
• People whose heart is functioning well enough, as shown by specific measurements on a heart scan (shortening fraction of 27% or more, or ejection fraction of 50% or more)
• People who have no breathing difficulties at rest, no difficulty with physical activity, and a blood oxygen level above 94% if checked
• People (and/or their parents or legal guardians) who are able to sign a written consent form

Who may not be able to join:

• People with certain related but different blood or lymph node cancers, including B-lymphoblastic lymphoma, Burkitt leukaemia/lymphoma, mature B-cell leukaemia, or mixed phenotype acute leukaemia
• People whose leukaemia has a specific genetic feature called the Philadelphia chromosome, or a related genetic change that responds to particular targeted drugs
• People whose cancer has a specific gene change involving MYC associated with a mature B-cell type of leukaemia, regardless of how the cancer cells appear under testing
• People who have previously had a stem cell (bone marrow) transplant
• People with a known inherited nerve condition called Charcot-Marie-Tooth disease
• People with an active, uncontrolled infection at the time of joining, including a recent positive bacterial blood culture, ongoing signs of infection while on antibiotics, a fever with signs of infection within 48 hours of joining, a recent positive fungal test, or an active viral or parasitic infection requiring intravenous treatment
• People with certain inherited conditions affecting the bone marrow or DNA repair, such as Bloom syndrome, ataxia-telangiectasia, Fanconi anaemia, Kostmann syndrome, Shwachman syndrome, or similar conditions
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection (people with these infections who have been successfully treated and have no detectable virus may still be considered — confirm with trial site)
• People with serious neurological conditions that could make treatment with blinatumomab unsafe, such as a history of severe neurological or autoimmune disease affecting the brain or spinal cord, or a history of stroke or brain bleed with remaining neurological effects (people with well-controlled epilepsy on stable medication may still be considered — confirm with trial site)
• People with an active autoimmune disease (some milder autoimmune conditions, such as well-controlled type 1 diabetes, thyroid conditions requiring only hormone replacement, or certain skin conditions not needing systemic treatment, may still be considered — confirm with trial site)
• People with Down syndrome who have cancer that has spread outside the bone marrow, brain/spinal fluid, or testes to other sites in the body
• People who are pregnant, or people who could become pregnant and have not had a negative pregnancy test within 7 days before joining
• People of reproductive potential who are not willing to use effective contraception for the duration of the trial and for a set period after treatment ends (at least 48 hours after the last dose of blinatumomab, and at least 5 months after the last dose of nivolumab)
• Male participants with female partners who could become pregnant are asked to use effective contraception during their treatment period
• People who are currently breastfeeding, or who are not willing to stop breastfeeding during treatment and for at least 48 hours after the last blinatumomab dose and 5 months after the last nivolumab dose

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