Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
150
Countries
4
Sites
5
Enteropathy-Associated T-Cell Lymphoma
Key facts
- Sponsor
- Seagen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Jun 2024 → 10 Dec 2025
- Decision date (initial)
- 2024-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502390-41-00
- ClinicalTrials.gov
- NCT06120504
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Enteropathy-Associated T-Cell Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10034623 | Peripheral T-cell lymphoma unspecified | 100000004864 |
| 21.1 | PT | 10002449 | Angioimmunoblastic T-cell lymphoma | 100000004864 |
| 20.0 | PT | 10073478 | Anaplastic large-cell lymphoma | 100000004864 |
| 21.1 | PT | 10002227 | Anaplastic large cell lymphoma T- and null-cell types | 100000004864 |
| 22.0 | PT | 10011677 | Cutaneous T-cell lymphoma | 100000004864 |
| 20.0 | PT | 10003899 | B-cell lymphoma | 100000004864 |
| 21.1 | PT | 10020206 | Hodgkin's disease | 100000004864 |
| 21.0 | PT | 10036710 | Primary mediastinal large B-cell lymphoma | 100000004864 |
| 22.0 | PT | 10029547 | Non-Hodgkin's lymphoma | 100000004864 |
| 20.0 | PT | 10073481 | Enteropathy-associated T-cell lymphoma | 100000004864 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 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
- Nicoleta Alexandru
Locations
4 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 10 | 1 |
| Germany | Ended | 10 | 1 |
| Italy | Ended | 5 | 1 |
| Spain | Ended | 10 | 2 |
| Rest of world
United States, Canada, United Kingdom
|
— | 115 | — |
Investigational sites
Rigshospitalet
Haematology and Phase 1 UniT, Blegdamsvej 9, 2100, Copenhagen Oe
Charite Research Organisation GmbH
Hemato-oncology, Hamato Onkologische Phase-I Unit, Hindenburgdamm 30, Berlin
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
SCDU Ematologia, Via Venezia 16, 15121, Alexandria
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 | 2024-10-02 | ||||
| Germany | |||||
| Italy | |||||
| Spain | 2024-06-20 | 2024-07-30 | 2024-10-07 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-51068
- Halt date
- 2024-10-07
- Member states concerned
- Denmark
- Publication date
- 2024-10-10
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the Cover Letter and DIL
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-51066
- Halt date
- 2024-10-07
- Member states concerned
- Spain
- Publication date
- 2024-10-10
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the Cover Letter and DIL
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-10 | Germany | Acceptable 2024-04-29
|
2024-04-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-03 | Acceptable | 2024-07-01 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-03 | Acceptable | 2024-06-28 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-03 | Acceptable | 2024-07-12 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-04 | Germany | Acceptable | 2024-07-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-30 | Germany | Acceptable 2025-08-04
|
2025-08-06 |