OBSERVATIONAL COHORT STUDY TO CHARACTERIZE THE SAFETY OF ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT) FOR PATIENTS WITH CLASSICAL HODGKIN LYMPHOMA (CHL) TREATED WITH NIVOLUMAB

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36390
• EU PAS number:
  EUPAS18444
• Study ID:
  36390
• Official title and acronym:
  OBSERVATIONAL COHORT STUDY TO CHARACTERIZE THE SAFETY OF ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT) FOR PATIENTS WITH CLASSICAL HODGKIN LYMPHOMA (CHL) TREATED WITH NIVOLUMAB
• DARWIN EU® study:
  No
• Study countries:
  France

  United States
• Study description:
  This study is an observational, database analysis using data collected in the Center for International Blood and Marrow Transplant Research (CIBMTR) registry to describe treatment-related mortality and other complications in patients with cHL treated with nivolumab prior to receiving an allogeneic hematopoietic stem cell transplantation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

The Medical College of Wisconsin

Study timelines

Date when funding contract was signed

Actual: 30/06/2016

Study start date

Planned: 31/03/2017

Actual: 31/03/2017

Data analysis start date

Planned: 01/10/2022

Date of interim report, if expected

Planned: 30/06/2019

Actual: 04/06/2019

Date of final study report

Planned: 31/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CA209-835