This phase 2 trial is evaluating the effectiveness of huCART19 cell therapy in young patients with high-risk B-cell acute lymphoblastic leukemia (ALL). The main outcome to be measured will be survival without a treatment-related complication. This study is being conducted in Philadelphia, Pennsylvania, United States.
Acute lymphoblastic leukemia a type of cancer of the blood and bone marrow. Chemotherapy is the typical first treatment for patients with ALL. However, some patients do not respond to this treatment, or experience relapse (the cancer comes back). T-cell therapy is another treatment option for these patients. T-cells (immune cells) are genetically modified to target cancer cells. Then, these T-cells are introduced to the patient.
This study is evaluating the effectiveness of huCART19 cell therapy in young patients with high-risk B-cell ALL. The main outcome to be measured will be event-free survival (time from diagnosis without a treatment-related complication).
Who are they looking for?
This trial is recruiting 85 patients. Patients with newly-diagnosed or recurrent B-cell ALL can participate. Patients who are ineligible for an allogeneic stem cell transplant can participate. Patients who had tumor shrinkage or did not respond to previous cell therapy can participate. They should have adequate organ function.
Patients with graft-versus-host disease (GVHD; a complication of stem cell transplant where the cells transplanted attack the patient) that requires therapy cannot participate. Patients with brain cancer or infections cannot participate. Pregnant or breastfeeding patients and those requiring steroid therapy cannot participate.
How will it work
This trial will involve two groups of patients. The first group will be patients with newly-diagnosed B-cell ALL. The second group will be patients who had a poor response to previous cell therapy. All patients will receive huCART19 cell therapy. Patients will be followed-up for 1 year.
Effectiveness will be measured as event-free survival at 1 year after treatment. Event-free survival will be measured in both groups of patients.