Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
70
Countries
3
Sites
7
Relapsed/refractory Non Hodgkin Lymphoma
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
- 24 Jan 2022 → 24 Feb 2025
- Decision date (initial)
- 2024-07-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511489-35-00
- EudraCT number
- 2020-005881-32
- ClinicalTrials.gov
- NCT04903197
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory Non Hodgkin Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 23.0 | PT | 10029600 | Non-Hodgkin's lymphoma recurrent | 100000004864 |
| 23.0 | PT | 10029601 | Non-Hodgkin's lymphoma refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- 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
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 8 | 3 |
| Italy | Ended | 12 | 2 |
| Spain | Ended | 10 | 2 |
| Rest of world
China, Singapore, United States, Australia, Japan, Korea, Republic of
|
— | 40 | — |
Investigational sites
University Hospital Cologne AöR
#1001: Centrum für Integrierte Onkologie (CIO), Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Leipzig AöR
#1003: Early Clinical Trials Unit, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsmedizin Goettingen
#1004: Hämatologie-Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
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 |
|---|---|---|---|---|---|
| Germany | 2024-04-10 | 2024-04-10 | 2024-08-29 | ||
| Italy | 2022-01-24 | 2022-01-24 | |||
| Spain | 2023-01-30 | 2023-01-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-44920
- Halt date
- 2024-08-29
- Member states concerned
- Germany
- Publication date
- 2024-09-09
- Reason
- Sponsor decision
- Follow-up measures
- At the time of enrollment halt decision (29-Aug-2024), there was 1 on-going patient in Germany who will complete the safety follow up for 6 months as per protocol (IMP treatment has been discontinued before enrollment halt)
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Germany | Acceptable 2024-07-02
|
2024-07-02 |