TK011: Prospective, non-interventional, post-authorisation safety study (PASS) of Zalmoxis prescribed in patients undergoing haploidentical hematopoietic stem cell transplantation for high-risk hematological malignancies

Study identification

• EU PAS number:
  EUPAS16894
• Study ID:
  46455
• Official title and acronym:
  TK011: Prospective, non-interventional, post-authorisation safety study (PASS) of Zalmoxis prescribed in patients undergoing haploidentical hematopoietic stem cell transplantation for high-risk hematological malignancies
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain
• Study description:
  The main objective of TK011 trial is to assess the short and long-term safety in routine clinical practice in adult patients affected by high-risk haematological malignancies, who receive Zalmoxis after a T-cell depleted haploidentical hematopoietic stem cell transplantation. In order to put the AEs of interest, defined by protocol, into context in a similar disease population, the background incidence of the stated important identified and potential risks will be determined in a non-randomized, concurrent control group of patients undergoing haploidentical transplantation without Zalmoxis prescription. No PASS trial will be conducted due to the withdrawal of the MAH in September 2019 Study timelines are not applicable as the PASS trial will not be conducted (inserted dates in section 3 are meant to be as "not applicable")
• Study status:
  Planned

Research institutions and networks

Institutions

MolMed

Networks

European Group for Blood and Marrow Transplantation (EBMT)

Study timelines

Date when funding contract was signed

Planned:31/03/2020

Study start date

Planned:01/07/2020

Data analysis start date

Planned:01/03/2021

Date of interim report, if expected

Planned:30/06/2021

Date of final study report

Planned:30/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MolMed

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)