A Non-Interventional Study (NIS) PASS to characterize secondary malignancies of T-cell origin following tisagenlecleucel therapy (CCTL019B2402)

Study identification

• EU PAS number:
  EUPAS1000000749
• Study ID:
  1000000749
• Official title and acronym:
  A Non-Interventional Study (NIS) PASS to characterize secondary malignancies of T-cell origin following tisagenlecleucel therapy (CCTL019B2402)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Brazil

  Canada

  Czechia

  France

  Germany

  Hong Kong

  Israel

  Italy

  Japan

  Korea, Republic of

  Netherlands

  Poland

  Russian Federation

  Saudi Arabia

  Singapore

  Spain

  Switzerland

  Taiwan

  United Kingdom

  United States
• Study description:
  This NIS PASS protocol CCTL019B2402 aims to provide a procedural framework to facilitate collection of existing participant samples (tumor and/or blood) for testing to address the potential risk for secondary malignancy of T-cell origin. There will be no treatment of patients.
• Study status:
  Planned

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Kyushu University Hospital, Tokyo Metropolitan Komagome Hospital, The University of Osaka Hospital, Osaka International Cancer Institute

Study timelines

Date when funding contract was signed

Planned:19/09/2025

Study start date

Planned:31/03/2026

Data analysis start date

Planned:31/08/2039

Date of final study report

Planned:15/06/2039

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

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)

Other study registration identification numbers and links

CCTL019B2402