Phase 2 Leukaemia 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 given written consent to take part (or whose legal representative has done so on their behalf)
• People aged 18–39 with a body mass index (BMI) of 30 or higher, or people aged 40–54 regardless of BMI
• People whose general health and ability to carry out daily activities falls within an accepted range for clinical trials (confirm with trial site)
• People newly diagnosed with a specific type of blood cancer called Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL), of either B-cell or T-cell type, as defined by World Health Organization standards
• People whose CD20 protein test is positive must have a white blood cell count below a certain level before starting treatment (confirm exact threshold with trial site); some may need brief pre-treatment to reduce cell counts
• People whose liver function blood test results (bilirubin, AST, and ALT) fall within acceptable ranges in the two weeks before starting treatment
• People whose kidneys are working at an acceptable level, based on a urine or formula-based test done in the two weeks before starting treatment
• People whose blood clotting test results (PT and aPTT) are within acceptable ranges in the two weeks before starting treatment
• People whose heart is pumping effectively, with a pumping function of at least 50%, confirmed by a heart scan done within six weeks before starting treatment
• People who test negative for active hepatitis B virus (CD20-positive patients only), tested within 28 days before starting treatment
• Women who could become pregnant must have a negative pregnancy test within two weeks before starting treatment
• People who are able and willing to use an effective non-hormonal method of contraception, or to abstain from heterosexual activity, for the entire study period and for at least 6 months after the last dose (or at least 12 months after the last dose for those receiving rituximab)

Who may not be able to join:

• People who have already received chemotherapy for their leukemia, with limited exceptions (such as brief steroid or hydroxyurea pre-treatment, a single dose of chemotherapy given directly into the spinal fluid, or a specific medication used when a different type of leukemia was suspected)
• People who have previously been treated with any form of the enzyme medication asparaginase
• People who have received, or are planning to receive, a live vaccine within two weeks before or after treatment; CD20-positive patients must not have received any vaccine (live or non-live) within four weeks before receiving rituximab
• People whose leukemia carries a specific genetic marker known as the Philadelphia chromosome (Ph+)
• People with severe heart failure classified as Class III or IV (those with controlled and symptom-free atrial fibrillation may still be considered)
• People whose leukemia or lymphoma has spread into the brain or spinal cord tissue
• People with a significant heart rhythm problem that has not been stable with treatment in the two weeks before joining
• People who have had a heart attack or serious chest pain episodes within the six months before joining
• People with a history of blood clots in the brain, repeated blood clots elsewhere, or a serious blood clot in the lungs (except clots related to a medical line or catheter)
• People with a history of severe pancreatitis (inflammation of the pancreas, grade 3 or higher)
• People with a history of heavy alcohol use, if the treating doctor considers this relevant
• People with a known allergy to medications that are chemically or biologically similar to the study drugs
• People with an active, uncontrolled infection
• People with another serious, uncontrolled medical condition
• People who currently have another active cancer
• Women who are pregnant or breastfeeding
• People with any other condition that the treating doctor believes would make participation unsafe
• People who, in the treating doctor's judgement, may not be able to follow all study requirements

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