Clinical trial • Phase I/II • Oncology
Acalabrutinib for Mantle cell lymphoma
Phase I/II trial of Acalabrutinib for Mantle cell lymphoma. open-label, none/not specified-controlled. 12 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Mantle cell lymphoma
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 01-07-2024
- First CTIS Authorization Date
- 29-07-2024
Trial design
open-label, none/not specified-controlled Phase I/II trial across 2 sites in Poland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 12
Eligibility
Recruits 12 Vulnerable population selected (isVulnerablePopulationSelected: true); no further details on consent or assent handling provided in the source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true); no further details on consent or assent handling provided in the source.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 128
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 12
Poland
- Latest Decision Or Authorization Date
- 29-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Krakow
- Principal Investigator Name
- Wojciech Jurczak
- Principal Investigator Email
- wojciech.jurczak@pratia.com
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- wojciech.jurczak@pratia.com
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii – Klinika Hematologii
- Principal Investigator Name
- Tadeusz Robak
- Principal Investigator Email
- robaktad@csk.umed.lodz.pl
- Contact Person Name
- Tadeusz Robak
- Contact Person Email
- robaktad@csk.umed.lodz.pl
Sponsor
Primary sponsor
- Full Name
- Acerta Pharma B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Acalabrutinib
- Active Substance
- Acalabrutinib
- Modality
- Small molecule
- Investigational Product Name
- Bendamustine
- Active Substance
- Bendamustine
- Modality
- Small molecule
- Investigational Product Name
- Rituximab
- Active Substance
- Rituximab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Venetoclax
- Active Substance
- Venetoclax
- Modality
- Small molecule
- Combination Treatment
- Yes
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