Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
58
Countries
1
Sites
9
Relapsed/refractory B-cell aggressive lymphoma
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 May 2024 → ongoing
- Decision date (initial)
- 2024-01-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory B-cell aggressive lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10007995 | Centroblastic lymphoma stage III | 10029104 |
| 21.0 | LLT | 10069643 | Intravascular large B-cell lymphoma | 10029104 |
| 21.0 | PT | 10006598 | Burkitt's lymphoma recurrent | 100000004864 |
| 21.1 | PT | 10065039 | Plasmablastic lymphoma | 100000004864 |
| 20.1 | PT | 10080215 | High-grade B-cell lymphoma | 100000004864 |
| 21.0 | PT | 10036710 | Primary mediastinal large B-cell lymphoma | 100000004864 |
| 21.0 | PT | 10006599 | Burkitt's lymphoma refractory | 100000004864 |
| 21.1 | PT | 10065857 | Primary effusion lymphoma | 100000004864 |
| 21.1 | LLT | 10042355 | Subcutaneous panniculitic T-cell lymphoma (Provisional subtype) stage IV | 10029104 |
| 20.1 | LLT | 10080211 | T-cell/histiocyte-rich large B-cell lymphoma | 10029104 |
| 21.1 | PT | 10008958 | Chronic lymphocytic leukaemia | 100000004864 |
| 20.1 | PT | 10079945 | Cutaneous lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
- Contact name
- Clinical Trials Unit
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
- Contact name
- Clinical Trials Unit
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 58 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Complexo Hospitalario Universitario De Santiago
Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
University Hospital Son Espases
Hematology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Central De Asturias
Hematologia y hemoterapia, Avenida De Roma S/n, 33011, Oviedo
University Clinical Hospital Virgen De La Arrixaca
Hematology, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Ico L'hospitalet Hospital Duran I Reynals
Hematology, Avinguda de la Granvia de l'hospitalet 199-203, 08908, Barcelona
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 |
|---|---|---|---|---|---|
| Spain | 2024-05-09 | 2024-05-27 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-19 | Spain | Acceptable 2023-12-20
|
2024-01-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-14 | Spain | Acceptable 2025-04-30
|
2025-05-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-05-13 | Spain | Acceptable 2026-06-25
|
2026-07-01 |