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:

• You have been diagnosed with a type of blood cancer called T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LL), and your cancer cells show a specific marker called CD7 on more than 98% of the abnormal cells
• Your cancer has come back (relapsed) at least once after standard chemotherapy, and there is evidence of cancer in your bone marrow
• Your cancer has come back after a stem cell transplant from a donor, as long as it has been at least 100 days since the transplant, you have no active graft-versus-host disease (a complication where donor cells attack your body), and you have not taken immune-suppressing medicines for at least 30 days
• Your cancer has spread to the brain or spinal fluid, or has been found in the eye or brain by biopsy
• Your cancer has spread outside the bone marrow to places such as the testes or other areas of the body
• Your cancer did not respond well enough to initial treatment (refractory disease), shown by persistent detectable cancer levels after consolidation chemotherapy
• You are between 6 months and 25 years of age
• You have suitable veins for the blood collection procedure (apheresis), or a catheter can be placed to allow this
• You (or your parent/guardian if you are under 18) are able and willing to give informed consent
• You are well enough to carry out at least 60% of normal daily activities, as measured by a standard medical scale appropriate for your age
• There is some measurable sign of cancer present at the time of joining the treatment phase (this may include very sensitive lab tests)
• Before starting treatment, a suitable stem cell donor (related or unrelated) is available for you

Who may not be able to join:

• You have a serious, uncontrolled active infection
• You have HIV, or currently active hepatitis C (HCV) or hepatitis B (HBV) infection
• More than 5% of the cells collected during the blood collection procedure are cancer cells (confirm with trial site)
• You have taken high-dose steroid medicines (equivalent to 2 mg/kg of prednisone or more) within the 2 weeks before the blood collection or treatment infusion (note: inhaled, skin-applied, or non-absorbed steroids are generally allowed)
• You have had systemic (whole-body) chemotherapy within the 2 weeks before the blood collection or treatment infusion
• You have been treated with certain specific medicines (nelarabine, daratumumab, or clofarabine) within 3 weeks before the blood collection procedure
• You have received certain immune-suppressing treatments (ATG or Alemtuzumab) within 8 weeks before the blood collection or treatment infusion
• You have received other immune-suppressing medicines within 2 weeks before the blood collection or treatment infusion
• You have had radiation therapy that was not completed at least 2–3 weeks before the blood collection or treatment infusion
• You have taken part in another experimental cancer treatment study within 30 days before the blood collection or treatment infusion
• You are pregnant or breastfeeding
• Your expected survival is less than 6 weeks
• Your liver is not working well enough (based on specific blood test results) (confirm with trial site)
• Your kidneys are not working well enough (based on specific blood test results) (confirm with trial site)
• Your blood oxygen level is below 90%
• Your heart is not pumping strongly enough (less than 45% pumping efficiency on an echocardiogram/heart scan)
• You have heart failure, an irregular heartbeat, uncontrolled seizures, raised pressure in the brain, reduced consciousness, or certain mental health or personal circumstances that could make it unsafe or difficult to take part
• You have active moderate-to-severe graft-versus-host disease (a complication from a previous stem cell transplant)
• The collected blood sample or the prepared treatment product contains more than 5% cancer cells

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