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Registration of CAR-T Cell therapies in EBMT Registry

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Interview with Debra Gordon, Registry Operational Manager, EBMT Registry Office, London

The number of registered cellular therapies is rapidly increasing.

On February 28th 2019, EBMT received a regulatory qualification from the European Medicines Agency (EMA) on the use of its patient registry to support novel CAR-T cell therapies. Read more here.

We have asked Debra Gordon, Registry Operational Manager in the EBMT Registry Office in London to answer our questions about the Cell Therapy Registry.

Question nº1: Can we document CAR-T cell therapies in ProMISe now or do we have to wait until MACRO is implemented?

Answer nº1: All CAR-T cell procedures can now be documented with the Cell Therapy Med-A Form which is located on our website https://www.ebmt.org/registry/data-collection

This reported data will later be migrated into MACRO.

Question nº2: Which CAR-T cell therapies should be documented? Only commercial available products?

Answer nº2: All CAR-T cell therapies should be documented, the currently commercially available Kymriah® and Yescarta® as well as investigational CAR-T cells, whether administered in the context of an industry-sponsored or academic trial.

Question nº3: Should also CAR-T cell treatment within clinical trials be documented?

Answer nº3: Yes, also CAR-T cell procedures which were performed in a clinical trial should be registered. For those CAR-T cell treatment it can be documented on the Cell Therapy Med-A Form that this treatment is part of a clinical trial and the data can be hidden until the date provided by the reporting data manager.

Question nº4: Who has access to the reported data?

Answer nº4: In line with EBMT policy, each center has access to its own data at all times. The data is also available for EBMT led studies. For other forms of data access EBMT is preparing a governance document for other possible stakeholders such as national registries, disease study groups, industry and Health authorities.

 

More about this story:

https://www.ebmt.org/ebmt/news/important-change-med-forms-cell-therapy (11 March 2019)