Phase 1 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 aged 0 to 29 years (patients aged 18 and over must give their own signed consent; for patients under 18, a parent or legal guardian must provide signed consent).
• People diagnosed with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) that has come back for a second time or more, has come back after a stem cell transplant, or has not responded to chemotherapy — with specific criteria around how this is confirmed (confirm with trial site).
• People whose cancer cells test positive for a protein called CD7 on at least 90% of the leukaemia or lymphoma cells.
• People with a history of, or current, central nervous system (CNS/brain and spinal cord) disease, as long as that disease is responding to treatment.
• People whose doctor considers them fit enough to undergo an intensive conditioning regimen and a stem cell transplant, and who have a matching donor identified at an approved transplant centre.
• People with a performance status score of 50 or above on the relevant scale for their age — this is a measure of how well a person is able to carry out daily activities (confirm with trial site).
• People who could become pregnant must have a negative pregnancy test at the screening stage.
• People whose kidneys, liver, lungs, and heart are functioning at or above the minimum levels required by the trial (confirm with trial site for specific thresholds).
• People who are sexually active and could become pregnant or father a child must agree to use a highly effective form of contraception from the time of consent until 12 months after receiving the trial treatment.

Who may not be able to join:

• People with active hepatitis B or hepatitis C infection.
• People with an active HTLV infection.
• People with HIV infection.
• People with a bacterial, viral, or fungal infection that is not currently under control.
• People whose CNS (brain/spinal cord) disease is getting worse despite treatment, or who have lesions in the brain tissue that could increase the risk of brain-related side effects.
• People with clinically active brain or nervous system problems, or a known history of permanent neurological damage caused by previous leukaemia treatment.
• People who have previously received a treatment that targets the CD7 protein.
• People who have had radiation therapy within the 2 weeks before completing the screening process, except for radiation used to prevent CNS disease.
• People experiencing graft-versus-host disease (GVHD — a complication that can occur after a transplant) at certain severity levels that require treatment with corticosteroid medicines.
• People who have had a stem cell transplant within the 90 days before completing screening, or a donor white blood cell infusion within the 30 days before completing screening.
• People who have any other condition that the investigating doctor determines would make them unsuitable for a stem cell transplant.
• People with a known primary immune deficiency or a condition where the bone marrow does not produce enough blood cells.
• People with atrial fibrillation or atrial flutter (certain irregular heart rhythms), unless these were isolated episodes that resolved with medical treatment.
• People with a clinically significant build-up of fluid around the heart.
• People who have had a heart attack within the last 12 months.
• People with a specific abnormality in the heart's electrical activity (QT interval corrected for heart rate above 480 milliseconds).
• People with significant heart failure classified at a certain severity level (NYHA class III or IV).
• People with an autoimmune condition that requires ongoing immune-suppressing medication that cannot safely be stopped for 3 months. Use of systemic corticosteroids for conditions unrelated to T-ALL/T-LLy is not permitted, except as a replacement therapy for adrenal insufficiency.
• People who are pregnant or breastfeeding.

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