NEWS
Publication: trial protocol
August, 2022 - The DUMAS protocol paper has been accepted for publication in Trials and can be found here.
Sixth safety interim analysis report to DSMB
January 17, 2022 - The DSMB has evaluated the results of the sixth safety interim analysis and interim analysis for dose adaptation: They recommend continuation of the study according to the current protocol. Also, they recommend that there be no change in current dosing of study drug, per protocol.
Isala Klinieken
October 3, 2021 – First patient included in Isala Klinieken, Zwolle
Fifth safety interim analysis report to DSMB
August 31, 2021 - The DSMB has evaluated the results of the fifth safety interim analysis and second interim analysis for dose adaptation: They recommend continuation of the study according to the current protocol. Also, they recommend that there be no change in current dosing of study drug, per protocol.
Second interim analysis for dose adaptation
May 4, 2021 – The DSMB has evaluated the results of the second interim analysis for dose adaptation: They recommended that there be no change in current dosing of study drug, per protocol.
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)
IRB approval
May 17, 2019 – IRB approval
First inclusion
Aug 10, 2019 – First patient included in the trial in the Erasmus MC, Rotterdam
Registration
November 26, 2018 – 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).