Long-term, Non-interventional Study of Recipients of Tecartus for Treatment of Adult Patients With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) or Adult Patients With R/R B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)

Study identification

• EU PAS number:
  EUPAS45813
• Study ID:
  50709
• Official title and acronym:
  Long-term, Non-interventional Study of Recipients of Tecartus for Treatment of Adult Patients With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) or Adult Patients With R/R B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Canada

  Czechia

  France

  Germany

  Israel

  Italy

  Netherlands

  Poland

  Portugal

  Spain

  Switzerland

  United Kingdom

  United States
• Study description:
  KT-EU-472-6036: This is a long-term, non-interventional study of adult patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL), who have been treated with Tecartus® after 2 or more lines of systemic therapy including a Bruton's tyrosine kinase inhibitor (BTK), and of adult patients (26 years of age and above in the EU and Great Britain [GB]; and 18 years of age and above in the US, Canada and Switzerland) treated with Tecartus for r/r B-cell precursor ALL.; ; The primary objective of this study is to evaluate effectiveness of Tecartus in terms of overall response rate for MCL and overall complete remission for ALL.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Kite

Study timelines

Date when funding contract was signed

Planned:31/08/2022

Actual:18/01/2023

Study start date

Planned:28/04/2023

Actual:18/04/2023

Date of final study report

Planned:31/03/2043

Sources of funding

More details on funding

Kite, A Gilead Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)