Clinical trial • Phase III • Oncology
Cusatuzumab for Acute myeloid leukemia
Phase III trial of Cusatuzumab for Acute myeloid leukemia. open-label, none/not specified-controlled. 40 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute myeloid leukemia
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 05-07-2024
- First CTIS Authorization Date
- 22-07-2024
Trial design
open-label, none/not specified-controlled Phase III trial across 3 sites in Germany.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 40
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 56
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 40
Germany
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 17-01-2025
- Processing Time Days
- 186
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Gene Center Laboratory for Translational Cancer Immunology
- Principal Investigator Name
- Marion Subklewe
- Principal Investigator Email
- marion.subklewe@med.uni-muenchen.de
- Contact Person Name
- Marion Subklewe
- Contact Person Email
- marion.subklewe@med.uni-muenchen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Internal medicine
- Principal Investigator Name
- Walter Fiedler
- Principal Investigator Email
- fiedler@uke.de
- Contact Person Name
- Walter Fiedler
- Contact Person Email
- fiedler@uke.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Department of hematology, cell therapy and Hemostaseology
- Principal Investigator Name
- Madlen Jentzsch
- Principal Investigator Email
- Madlen.Jentzsch@medizin.unileipzig.de
- Contact Person Name
- Madlen Jentzsch
- Contact Person Email
- Madlen.Jentzsch@medizin.unileipzig.de
Sponsor
Primary sponsor
- Full Name
- OncoVerity Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- OV-1001 (Cusatuzumab)
- Active Substance
- Cusatuzumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.