Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
50
Countries
2
Sites
9
Chronic lymphocytic leukemia
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Apr 2018 → 20 Apr 2026
- Decision date (initial)
- 2023-11-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508638-32-00
- EudraCT number
- 2017-001990-17
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic lymphocytic leukemia
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
- Jeanette Lundin
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Jeanette Lundin
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ended | 5 | 1 |
| Sweden | Ended | 45 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Karolinska University Hospital
Hematology, Eugeniavagen 3, 171 64, Solna
Region Oerebro Laen
Department of Internal Medicine, Department of Hematology, Sodra Grev Rosengatan, 701 85, Orebro
Region Dalarna
Hematology, Vasagatan 27, Falu Kristine, Falun
Region Gaevleborg
Hematology, Lasarettsvagen 1, 803 24, Gavle
Uppsala University Hospital
Hematology, Akademiska Sjukhuset, 751 85, Uppsala
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Hematology and Coagulation, Bruna Straket 16, 413 46, Gothenburg
Norrlands University Hospital
Department of Radiation Sciences, Oncology and Cancer center, Department of Hematology, Umea Universitet, 901 85, Umea
Lund University Hospital
Hematology, Getingevaegen 4, 222 42, Lund
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2022-05-12 | 2026-04-20 | 2022-05-19 | 2022-07-28 | |
| Sweden | 2018-04-06 | 2026-04-20 | 2018-04-10 | 2022-07-28 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-09 | Sweden | Acceptable 2023-11-07
|
2023-11-08 |