Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
60
Countries
1
Sites
7
Follicular Lymphoma
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- completed 1 Dec 2022
- Decision date (initial)
- 2022-10-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Follicular Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10016903 | Follicle centre lymphomas follicular grade I II III | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Coordinating Investigator
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Coordinating Investigator
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 60 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Nu Hospital Group-Vastra Goetalandsregionen
Uddevalla Hospital, Dept. of Hematology, Larketorpsvagen, 461 85, Trollhattan
Lanssjukhuset Kalmar Region Kalmar Lan
Dept. of Hematology, Lasarettsvagen 8, Kalmar S:t Johannes, Kalmar
Sahlgrenska University Hospital - Västra Götalandsregionen
undefined, Diagnosvagen 11, Harlanda, Gothenburg
Linkoping University Hospital Region Ostergotland
undefined, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Karolinska University Hospital
Dept of Hematology, Eugeniavagen 3, 171 64, Solna
Uppsala University Hospital
Dept. of Immunology, Genetics and Pathology, Akademiska Sjukhuset, 751 85, Uppsala
Sankt Gorans Sjukhus
Dept. of Medicine, Sankt Goransplan 1, Vastermalm, Stockholm
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-06-28 | Sweden | Acceptable with conditions 2022-10-10
|
2022-10-14 |