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).