See below the full text related to: the Informed Consent Form, the agreements, and Data reporting. Read on.
Informed Consent Form
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.
Agreements
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.
Data reporting
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.
Study update
Patient enrollment for the Data Collection Initiative has now been closed for the following CAR-T products and corresponding indications:
- Kymriah® - Enrollment closed on 24 April 2023.
- 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
- Adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
- Yescarta® - Enrollment closed on 31 December 2023.
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL).
- Abecma® - Enrollment closed on 4 June 2024.
- Adult patients with multiple myeloma.
- Tecartus® - Enrollment closed on 16 October 2024.
- Adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
- Breyanzi® - Enrollment closed on 21 February 2025.
- Adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma (HGBCL), and follicular lymphoma grade 3B (FL3B)
Important information
- Patients reported after the applicable enrollment closure date are not eligible for reimbursement.
- All enrolled patients have been confirmed with the respective participating sites and must continue to be followed for 15 years after treatment, or until death, in accordance with the Data Collection Initiative requirements.
Open for Enrollment
Enrollment is currently open for:
- Tecartus® - Adult patients (26 years of age and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Additional CAR-T products and indications are expected to be added to the Data Collection Initiative in the near future.