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EBMT & CIBMTR: Harmonizing cellular therapy forms

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EBMT and CIBMTR worked in partnership to harmonize data collection on cellular therapies to ensure a strong collaborative relationship. The content of the CIBMTR cellular therapy forms suite and their corresponding MED-C forms from EBMT were recently reviewed. The harmonization effort focused on reviewing each question asked in both registries’ forms to better align them. Forms are compared in both directions: CIBMTR to EBMT and EBMT to CIBMTR. Questions asked by one registry and not the other are reviewed and may be incorporated in subsequent revisions. Once questions are aligned, the variables related to these questions are then mapped to facilitate future data merges for collaborative studies or projects.

After initial harmonization work began in 2018, the group began routinely meeting in January 2020 to review recent form modifications. The group reviewed all CT forms. The next step is to harmonize the disease specific forms frequently used for patients receiving CAR T cells.

Both EBMT and CIBMTR have contracts with Kite and Novartis to follow patients who receive their respective CD 19 CAR T cells as part of the manufacturers’ post market regulatory obligations. As these are global products, this ongoing collaboration allows the organizations to continue serving as a resource to the community, capturing data on CAR T cell therapies both now and in the future. Due to differences in regulatory frameworks, this approach (using US and Europe-based registries to capture long term outcomes on recipients of CAR T cells) is considered most efficient. Participating centers can use a single infrastructure to report all products, maximizing ease of reporting and participation.

This collaboration prepares both organizations for the future by providing a mechanism to discuss emerging therapies for other indications, including creating parallel mechanisms to appropriately capture outcomes on gene therapies.

This initiative is part of a combined broader effort to work together. We are grateful to be part of this process and excited for the future.

The EBMT group includes Christian Chabannon, Marianne Mol, Debra Gordon, Lucas Stolarczyk, Marco Bressers, Steffie Van Der Werf, Annelot Van Amerongen, and Sofie Terwel. From the CIBMTR, Marcelo Pasquini, Sharon Graminske, Bob Thompson, Tiffany Hunt, Jaime Santi, and Carlos Litovich participated in these conversations.