Study identification

EU PAS number

EUPAS1000000047

Study ID

1000000047

Official title and acronym

Postauthorization Safety Study Survey to Evaluate the Effectiveness of the Ciltacabtagene Autoleucel HCP Educational Program and the Product Handling Training

DARWIN EU® study

No

Study countries

Austria
Germany
Switzerland

Study description

This is a category 3 PASS study with the objective of measuring the effectiveness of the healthcare professional (HCP) Educational Program, an additional risk minimization measure intended to increase awareness about the risks of cytokine release syndrome (CRS) (including hemophagocytic lymphohistiocytosis) and neurologic toxicity (including immune effector cell associated neurotoxicity syndrome and other neurotoxicities); as well as the potential risk of cell viability due to inappropriate handling or preparation of the product, and the HCP awareness of the need to provide patients of a patient CAR-T Journey Guide with its enclosed Patient Alert Card to improve their understanding of the risks associated with CAR-T therapy and how to better manage them.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Siobhan Murphy

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Fully funded by Johnson and Johnson
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)