Foresight Protocol
Outcomes in Pediatric and Young Adult B-Cell Malignancies after Commercially Available Immunotherapy
This is a multi-institutional retrospective and prospective data (limited PHI) and correlative research sample collection protocol designed to conduct in-depth analyses of children and young adults with B-cell malignancies undergoing (or who have undergone) tisagenlecleucel, blinatumomab and/or inotuzumab therapy, to establish early and late response and toxicity rates, evaluate the impact of patient, disease and treatment factors on clinical outcomes. Arm A is currently launched and below is a schema of our active efforts to date.​​​
(NCT05865301)
RWE 2025 Protocol
Outcomes in Pediatric and Young Adult B-Cell Acute Lymphoblastic Leukemia after Immunotherapy
This amendment of the RWE 2019 protocol was launched in 2025 and collects retrospective, limited PHI dataset across participating international and national institutions to analyze ‘real world’ data generated across institutions that delivered immunotherapy, including Kymriah as a standard of care therapy, to pediatric and young adult patients with relapsed/refractory B-ALL.
The study additionally captures the WeCARe PRO survey.​​​
RWE 2019 Protocol - Not Active
Outcomes in Pediatric and Young Adult B-Cell Acute Lymphoblastic Leukemia after Kymriah™ (Tisagenlecleucel) as an FDA-approved therapy
Launched in 2019, this study collected retrospective de-identified data across 20 participating institutions to analyze ‘real world’ data generated across institutions that delivered Kymriah as a standard of care therapy to pediatric and young adult patients with relapsed/refractory B-ALL. Given the data collected was retrospective and de-identified, this project did not meet the definition of human subject research as defined in federal regulations 45 CFR 46.102 or 21 CFR 50.3.​
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The conclusions of this study yielded multiple outcomes reporting on pediatric and young adult recipients of commercial CART cell therapy. These works additionally identified clinical covariates associating with distinct outcomes. These finding can be found in manuscripts and abstract under Publications.
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This protocol gave rise to additional limited data collection projects. Some of these collections are ongoing but can be continued through the Foresight protocol.