Pediatric Acute Leukemia Inititative

Headquarters: Leukemia & Lymphoma Society
Website: lls.org/pedal

PedAL is a collaborative effort sponsored by the Leukemia & Lymphoma Society to enable a precision medicine approach to pediatric relapsed, refractory, and high risk leukemias. By changing the paradigm for pediatric leukemia clinical trialsĀ  to one that is internationally integrated and collaborative, PedAL aims to accelerate the testing of new precision medicine therapies and change how we develop novel, targeted therapies in the treatment of children with relapsed leukemia.

The centerpiece of PedAL is an integrated multi-site, multi-therapy Master Clinical Trial. By creating a new, collaborative model for pediatric leukemia clinical trials PedAL will support the creation of the regulatory and technical infrastructure for data aggregation and sharing. The aims of this new model include creating operational and cost efficiencies in study management, making data from different sources interoperable, easily identifying appropriate patients for new therapies, and consolidating clinical and scientific data from institutes and consortia nationwide.

Our Role

To achieve its goals, PedAL requires a robust data infrastructure that supports a wide variety of research and clinical activities, including real-time data collection, harmonization of historical data, and data mining to match patients to clinical trials. As the leaders of the bioinformatics component of PedAL, our team will develop and deploy the three-part data platform on which the pilot project will run.

The PedAL Platform will be used at project sites for registration and data integration, and will feed data to the other two components of the platform, GEARBOx and the PedAL Data Commons.

GEARBOx (Genomic Eligibility Algorithm at Relapse for Better Outcomes) will address the important task of matching patients with relapsed or refractory disease to appropriate clinical trials accurately and rapidly. Clinical researchers will use this web-based tool to search for treatments based on the clinical, immunophenotype, and genomic profiles of their patients. GEARBOx will use a matching algorithm to build a list of appropriate trials based on its database of COG eligibility criteria, connecting patients to lifesaving treatments.

The third component of the PedAL infrastructure will power research by bringing together large amounts of pediatric leukemia data into one unified Data Commons. The PedAL Data Commons will include historical data to be used in conjunction with new data that is added. All data will be harmonized to a universal acute myeloid leukemia (AML) data dictionary. This unique platform will power research by including data linkage, cohort outcomes tracking, and analysis tools.

Currently, our team is focusing on several key areas: developing the AML data dictionary, connecting various data sources and harmonizing historical data for the PedAL Data Commons, and building and deploying the three-part system for researchers. We are also applying our expertise in the areas of data privacy, security, and legal regulations to develop and follow appropriate policies and procedures to protect patients.