Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
78
Countries
4
Sites
7
Relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL)
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Oct 2022 → 9 Jan 2026
- Decision date (initial)
- 2024-02-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507430-25-00
- EudraCT number
- 2022-000367-45
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10025311 | Lymphoma (non-Hodgkin's) | 10029104 |
| 21.0 | LLT | 10000844 | Acute lymphoblastic leukaemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 6 | 1 |
| France | Ended | 8 | 2 |
| Italy | Ended | 6 | 2 |
| Spain | Ended | 12 | 2 |
| Rest of world
Singapore, Israel, United States, Japan
|
— | 46 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
#2001:Unite Hemopathies Lymphoides, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Institut Paoli-Calmettes
#2000:Hematologie 4, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Azienda USL IRCCS Di Reggio Emilia
6002:S.C. Ematologia, Viale Risorgimento 80, 42123, Reggio Emilia
Humanitas Mirasole S.p.A.
6003:U. O. Oncologia Medica ed Ematologia Humanitas Cancer Center, Via Alessandro Manzoni 56, 20089, Rozzano
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 | 2024-04-23 | 2024-04-23 | 2025-01-15 | ||
| France | 2022-10-03 | 2022-10-03 | 2025-09-08 | ||
| Italy | 2025-05-08 | 2025-05-08 | 2025-08-19 | ||
| Spain | 2023-05-09 | 2023-05-09 | 2025-05-27 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-20 | Belgium | Acceptable 2024-02-12
|
2024-02-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-05 | Belgium | Acceptable 2024-07-01
|
2024-07-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-19 | Belgium | Acceptable with conditions 2025-03-07
|
2025-03-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-08 | Belgium | Acceptable 2025-12-18
|
2025-12-18 |