Clinical trial • Phase III • Oncology
MOSUNETUZUMAB for Follicular lymphoma
Phase III trial of MOSUNETUZUMAB for Follicular lymphoma. Randomised, open-label, anti-cd20 monoclonal antibody plus chemotherapy-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Follicular lymphoma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 21-12-2023
- First CTIS Authorization Date
- 29-04-2024
Trial design
Randomised, open-label, anti-cd20 monoclonal antibody plus chemotherapy-controlled Phase III trial across 1 site in Belgium.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- anti-CD20 monoclonal antibody plus chemotherapy
Eligibility
Recruits 1 No vulnerable population selected; no details on consent or assent provided..
- Vulnerable Population
- No vulnerable population selected; no details on consent or assent provided.
Inclusion criteria
- {"criterion_text":"- N/A"}
Exclusion criteria
- {"criterion_text":"- N/A"}
Endpoints
Primary endpoints
- {"endpoint_text":"- N/A","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- N/A","definition_or_measurement_approach":""}
Recruitment
- Recruitment Window Months
- 118
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 1
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-11-2023
- Latest Decision Or Authorization Date
- 29-04-2024
- Processing Time Days
- 171
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Dantestraat 75
- Department Name
- dummy information
- Contact Person Name
- dummy information dummy information
- Contact Person Email
- EU.CTSubmissions@roche.com
- Number Of Participants
- 1
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Mosunetuzumab
- Active Substance
- MOSUNETUZUMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- prodAuthStatus=1
- Maximum Dose
- 45 mg (max daily), 1035 mg (max total)
- Investigational Product Name
- Mosunetuzumab
- Active Substance
- MOSUNETUZUMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- prodAuthStatus=1
- Maximum Dose
- 45 mg (max daily), 1035 mg (max total)
- Combination Treatment
- Yes
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