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:

• Children, teenagers, and young adults (aged 1 to under 25) diagnosed with B-cell acute lymphoblastic leukemia (a type of blood cancer) that has come back after treatment or did not respond to initial treatment.
• People whose cancer cells make up at least 5% of cells in the bone marrow or blood, and those cells carry specific markers called CD19 and CD22.
• People who are either unable to receive a certain type of chemotherapy drug (anthracyclines) or who cannot tolerate a medicine called PEG-asparaginase.
• People who do not have the CD20 marker on their cancer cells may still be considered, though one specific medication (rituximab) would not be given in that case.
• People who are well enough to carry out some daily activities, as measured by age-appropriate medical scoring tools (Lansky score of 50 or higher for those 16 and under; Karnofsky score of 50% or higher for those over 16).
• People whose leukemia has spread to the brain or spinal cord but who are not currently experiencing symptoms from it.
• People whose liver, kidney, and other blood test results fall within acceptable ranges as defined by the trial.
• People with certain heart conditions, including reduced heart pumping function or those who have already received high doses of a specific heart-affecting chemotherapy drug and cannot receive more.
• Females of childbearing potential who test negative for pregnancy within 14 days before starting the trial and who agree to use effective contraception during the trial and for a specified period afterward (up to 12 months after the last dose, depending on the medication).
• Males who agree to use a condom during the trial and for a specified period afterward, and who agree not to donate sperm during that time.

Who may not be able to join:

• People who have had, or currently have, a second or different type of cancer, or a specific form of leukemia called CML blast crisis — with limited exceptions for certain fully treated skin or solid cancers with no current signs of disease.
• People with serious, uncontrolled brain or nervous system conditions such as epilepsy, stroke, severe brain injury, or psychosis (headaches, vomiting, or nerve palsy are generally acceptable).
• People with significant heart problems, such as moderate-to-severe heart failure or serious heart rhythm abnormalities that require medication.
• People with active, uncontrolled infections (those with infections being managed with anti-infective medications may still be considered).
• People with known active hepatitis B, hepatitis C, or HIV infection.
• People with liver cirrhosis, other serious active liver disease, or suspected active alcohol misuse.
• People with active graft-versus-host disease (a complication after certain transplants) requiring ongoing treatment, or who have received transplant-related immune-suppressing medications within the 2 weeks before starting the trial.
• People who have not yet recovered from side effects of previous chemotherapy, surgery, or radiation treatment.
• Females who are pregnant or breastfeeding.
• People who are unwilling or unable to use approved contraception during the trial and for the required period afterward.
• People with Down syndrome (Trisomy 21) or bone marrow failure conditions.
• People who have previously had an allergic reaction to any of the medications used in this trial.
• People who are unable or unwilling to attend all required clinic visits, tests, and appointments.
• People currently taking part in another clinical trial involving experimental treatments.
• People with other serious uncontrolled medical or psychiatric conditions that the trial doctor believes could affect safety or the trial's results (confirm with trial site).

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