Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
210
Countries
5
Sites
8
Lymphoma, Large B-Cell, Diffuse
Key facts
- Sponsor
- Seagen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Sep 2024 → 9 Apr 2026
- Decision date (initial)
- 2024-07-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505813-26-00
- ClinicalTrials.gov
- NCT06254495
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Lymphoma, Large B-Cell, Diffuse
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073478 | Anaplastic large-cell lymphoma | 100000004864 |
| 21.1 | PT | 10034623 | Peripheral T-cell lymphoma unspecified | 100000004864 |
| 21.1 | PT | 10020206 | Hodgkin's disease | 100000004864 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 21.1 | PT | 10002227 | Anaplastic large cell lymphoma T- and null-cell types | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Seagen Inc.
- Sponsor organisation
- Seagen Inc.
- Address
- 21823 30th Drive Southeast
- City
- Bothell
- Postcode
- 98021-3907
- Country
- United States
Scientific contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Trial Information Support
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Trial Information Support
Locations
5 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 6 | 1 |
| France | Ended | 24 | 4 |
| Germany | Ended | 6 | 1 |
| Italy | Ended | 6 | 1 |
| Spain | Ended | 6 | 1 |
| Rest of world
United States, United Kingdom
|
— | 162 | — |
Investigational sites
Rigshospitalet
Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Universitaire De Montpellier
Hematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Lyon Sud
Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Caen Normandie
Hematology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Institut Gustave Roussy
Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
Charite Universitaetsmedizin Berlin KöR
Charité Campus Benjamin Franklin, Early Clinical Trials Unit, Hindenburgdamm 30, Lichterfelde, Berlin
Centro Ricerche Cliniche Di Verona S.r.l.
Hematology section, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
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 |
|---|---|---|---|---|---|
| Denmark | 2024-11-04 | 2024-12-03 | 2025-08-28 | ||
| France | 2025-04-23 | 2025-08-06 | 2025-08-28 | ||
| Germany | 2025-05-13 | ||||
| Italy | 2024-09-12 | 2024-10-07 | 2025-08-28 | ||
| Spain | 2024-12-18 | 2025-02-13 | 2025-08-28 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-08 | Germany | Acceptable 2024-07-26
|
2024-07-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-22 | Acceptable | 2024-11-08 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-22 | Acceptable | 2024-09-20 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-22 | Germany | Acceptable | 2024-10-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-22 | Acceptable | 2024-10-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-22 | Acceptable | 2024-10-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-19 | Germany | Acceptable 2025-04-07
|
2025-04-07 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-13 | Germany | Acceptable 2025-06-30
|
2025-06-30 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-10 | Acceptable 2026-03-30
|
2026-04-01 |