Study of Outcomes in Children and Young Adults Up to 26 Years With B-Cell Leukemia or Lymphoma Receiving Commercial Immunotherapy

What this Trial Is About

Researchers are studying children and young adults with B cell precursor acute lymphoblastic leukemia ALL or B cell lymphoma to understand outcomes after receiving commercially available immunotherapy treatments such as blinatumomab, inotuzumab ozogamicin, and tisagenlecleucel Kymriah. The study includes both retrospective and prospective data collection to evaluate these therapies in real-world settings. Participants are divided into two groups Arm A includes those who have undergone standard of care tisagenlecleucel therapy and provide retrospective data Arm B involves patients undergoing evaluation or treatment with tisagenlecleucel, blinatumomab, or inotuzumab and participate in prospective biological sample collection. Both groups complete questionnaires at multiple timepoints, including baseline and up to 12 months post-infusion, covering demographics, socioeconomic factors, barriers to care, and patient-reported outcomes following CAR T cell therapy. During the study, participants complete surveys such as the WECARE survey at baseline and up to 12 months after therapy. Researchers will assess overall survival, event-free survival, and duration of remission. The study involves follow-up visits for questionnaires and biological sample collection, with data gathered to better understand patient experiences and treatment outcomes over time. The trial is observational and sponsored by Stanford University, with a maximum participant age of 26 years.

Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy