Set-up of the Data Collection Initiative to support the PAS studies

The adapted consent form allows patient level data to be shared with EBMT’s Collaboration partners, such as MAHs and the EMA for the sole purpose of supporting PAS studies and ultimately, regulatory decision making.

EBMT has amended its patient informed consent form (ICF) to allow patients to choose to share their pseudonymised data with EBMT’s collaboration partners, for example MAHs for research purposes. This means that there will be no separate ICF for individual PAS studies, but a general ICF that can be used to support PAS studies for currently available as well as future CAR-T therapies. Until this ICF is approved by the applicable regulatory authorities and the patient has (re)consented, data will be shared only in aggregate reports.

This new ICF was also implemented in May 2022 for all Registry patients.

To participate in the Data Collection Initiative a centre must sign the Data Collection Master Agreement and a Product-Specific Agreement. In addition, all EBMT centres should sign a Joint Controllership Agreement.

The contracts for the Data Collection Initiative on CAR-T are split in two parts. The Data Collection Master Agreement governs the general data collection requirements that are identical for all CAR-T therapies. Whereas the short Product-Specific Agreements specify additional requirements for the individual CAR-T therapies. For each new PAS study, you will only need to sign a new Product-Specific Agreement. 

We also remind your centre to sign the Joint Controllership Agreement (JCA), which stipulates that all data processing is done in compliance with the GDPR. This document governs all data processing activities between EBMT and the centre and is thus a prerequisite but not specific for the PAS studies. The JCA should be signed by all centres, including those who do not participate in the Data Collection Initiative on patients treated with CAR-T.

Report data on all patients treated with CAR-T therapy within six weeks of the patient's treatment or follow-up visit(s).

Data collection per the regular data collection forms and procedures does not require additional contracts and regulatory approvals. We thus ask you to report data on all patients treated with CAR-T therapy within six weeks of treatment or any follow-up visit(s) which are expected around day 100, 6 months and then yearly for up to 15 years.

The patient enrollment for the Data Collection Initiative is currently still open for:

• Breyanzi® Enrollment continues until the inclusion target of 200 patients in Europe has been reached (competitive enrollment). The following indications are eligible for enrollment: adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B)
• More products and/or additional indications are expected to follow in the near future.

The patient enrollment for the Data Collection Initiative has been closed for 4 commercial CAR-T products: 

• Kymriah® The enrollment was closed on 24 April 2023. The following indications were eligible for enrollment: pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). 
• Yescarta® The enrollment was closed on 31 December 2023. The following indications were eligible for enrollment: adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL).
• Abecma® The enrollment was closed on 4 June 2024. The following indication was eligible for enrollment: adult patients with multiple myeloma.
• Tecartus® The enrollment was closed on 16-Oct-2024. The following indication was eligible for enrollment: adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Any patients reported after the enrollment closure date will not be reimbursed. 

All enrolled patients have been confirmed to the individual sites and all enrolled patients will need to be followed-up for 15 years (or until death).