Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
194
Countries
4
Sites
15
Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Key facts
- Sponsor
- ADC Therapeutics SA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Mar 2022 → ongoing
- Decision date (initial)
- 2024-04-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512089-32-00
- EudraCT number
- 2021-001071-16
- ClinicalTrials.gov
- NCT04970901
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10084346 | B-cell non-Hodgkin´s lymphoma | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ADC Therapeutics SA
- Sponsor organisation
- ADC Therapeutics SA
- Address
- Route De La Corniche 3b
- City
- Epalinges
- Postcode
- 1066
- Country
- Switzerland
Scientific contact point
- Organisation
- ADC Therapeutics SA
- Contact name
- ADC Therapeutics SA
Public contact point
- Organisation
- ADC Therapeutics SA
- Contact name
- ADC Therapeutics SA
Locations
4 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 22 | 2 |
| Czechia | Ongoing, recruiting | 23 | 4 |
| Italy | Ongoing, recruiting | 35 | 4 |
| Spain | Ongoing, recruiting | 41 | 5 |
| Rest of world
United States, United Kingdom
|
— | 73 | — |
Investigational sites
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Fakultni Nemocnice Kralovske Vinohrady
Hematologická klinika, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice V Motole
Onkologická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O.C. Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
SC Ematologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Unità linfomi e sindromi linfoproliferative croniche -, Via Pietro Albertoni 15, 40138, Bologna
Istituto Europeo Di Oncologia S.r.l.
Unità di Oncoematologia, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitario Ramon Y Cajal
Hematology Department, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
Hematology Department, Calle Del Doctor Esquerdo 46, 28007, Madrid
Institut Catala D'oncologia
Lymphoma Unit, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
Hematology Department, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Salamanca
Hematology Department, Paseo De San Vicente 58-182, 37007, Salamanca
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 |
|---|---|---|---|---|---|
| Belgium | 2022-05-05 | 2023-08-25 | |||
| Czechia | 2022-05-24 | 2023-01-31 | |||
| Italy | 2022-06-24 | 2022-10-31 | |||
| Spain | 2022-03-28 | 2022-09-29 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-29 | Belgium | Acceptable 2024-04-05
|
2024-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-30 | Belgium | Acceptable with conditions 2024-12-02
|
2024-12-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-09 | Belgium | Acceptable with conditions 2025-03-25
|
2025-03-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-02 | Belgium | Acceptable with conditions 2025-11-20
|
2025-11-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-17 | Belgium | Acceptable 2026-02-24
|
2026-02-25 |