NEWS

First interim analysis for dose adaptation

January 20th, 2021 – The DSMB has evaluated the results of the first interim analysis for dose adaptation: They recommended that there be no change in current dosing of study drug. Additionally, they have no safety concerns and recommend to continue the study as planned.

Fourth safety interim analysis report to DSMB

Oct 26, 2020 - The DMSB has evaluated our fourth report and identified no safety concerns, and recommended that the study continued as planned.

Third safety interim analysis report to DSMB

Aug 12, 2020 - The DMSB has evaluated our report on the first 40 cases included in DUMAS and identified no safety concerns, and recommended that the study continued as planned.

Reinier de Graaf hospital

July 13, 2020 – First patient included in the Reinier de Graaf hospital, Delft

Second safety interim analysis report to DSMB

April 09, 2020 - The DMSB chaired by prof Michael Hill from Calgary has evaluated our report on the first 31 cases included in DUMAS and identified no safety concerns, and recommended that the study continued as planned.

First safety interim analysis report to DSMB

February 02, 2020 - First safety interim analysis report to DSMB: no safety concerns.

Registration

February 05, 2020 - We are also registered under NCT04256473 ( https://clinicaltrials.gov/ct2/show/NCT04256473)

December 04, 2019 – We are registered under NL7409 (NTR7634) ( https://www.trialregister.nl/trial/7409). The NTR is part of the World Health Organization (WHO) International Clinical Trial Registry Platform (http://apps.who.int/trialsearch/), where DUMAS can be found as well (http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NTR7634).

IRB approval

May 17, 2019 – IRB approval

First inclusion

 Aug 10, 2019 – First patient included in the trial in the Erasmus MC, Rotterdam