Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
22
Countries
1
Sites
6
Oncology: RELAPSED PRIMARY CNS LYMPHOMA
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Feb 2025 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511900-17-00
- EudraCT number
- 2021-000210-42
- ClinicalTrials.gov
- NCT05135858
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Oncology: RELAPSED PRIMARY CNS LYMPHOMA
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 21.0 | LLT | 10036685 | Primary central nervous system lymphoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Caroline HOUILLIER
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Sabrina AYADI
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 22 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
CHRU De Nancy
Neuro-oncology, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Assistance Publique Hopitaux De Paris
Neuro-oncology, 43 Boulevard De L Hopital, 75013, Paris
CHU d'Estaing
Hematology, 1 place Lucie et Raymond Aubrax, 63100, Clermont-Ferrand
Assistance Publique Hopitaux De Paris
Hematology, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Institut De Cancerologie Strasbourg Europe
Hematology, 17 Rue Albert Calmette, 67200, Strasbourg
Assistance Publique Hopitaux De Paris
Neuro-oncology, 1 Avenue Claude Vellefaux, 75010, Paris
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 |
|---|---|---|---|---|---|
| France | 2022-09-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-64765
- Halt date
- 2024-11-08
- Member states concerned
- France
- Publication date
- 2024-12-23
- Reason
- Medicinal Product related
- Explanation
- The current stock of VORAXAZE® supplied by the industrial partner expires on December 31, 2024.
This stock could guarantee treatment for patients enrolled until November 8, 2024, but not beyond that date.
In fact, it would not guarantee a complete cycle for patients included after this date.
A new order of VORAXAZE® will be ready by the end of January 2025, ensuring the continuity of supply.
To prevent any situation where patients are enrolled without available treatment, a preventive measure has been taken to avoid the inclusion of new patients before the new stock is available.
There are currently no patients undergoing treatment. - Follow-up measures
- There are currently no patients undergoing treatment.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-28 | France | Acceptable 2024-10-29
|
2024-10-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-02-24 | France | Acceptable 2024-10-29
|
2025-02-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-31 | France | Acceptable 2025-06-27
|
2025-07-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-04-02 | France | Acceptable 2025-06-27
|
2026-04-02 |