Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
39
Countries
2
Sites
7
Myeloid malignancies with moderate or severe hepatic impairment or normal hepatic function
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 10 Nov 2023 → 25 Nov 2025
- Decision date (initial)
- 2023-08-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503427-26-00
- WHO UTN
- U1111-1287-2662
- ClinicalTrials.gov
- NCT05209295
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myeloid malignancies with moderate or severe hepatic impairment or normal hepatic function
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10054350 | Chronic myelomonocytic leukemia | 10029104 |
| 20.0 | LLT | 10068361 | MDS | 10029104 |
| 21.0 | LLT | 10028576 | Myeloproliferative disorder | 10029104 |
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
| 21.1 | PT | 10075460 | Blastic plasmacytoid dendritic cell neoplasia | 100000004864 |
| 21.1 | LLT | 10060557 | Acute myelocytic leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 7 | 3 |
| Spain | Ended | 7 | 4 |
| Rest of world
Argentina, Colombia, United States
|
— | 25 | — |
Investigational sites
University Hospital Augsburg
II. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
University Hospital Halle (Saale)
Krukenberg-Krebszentrum Halle, Klinik für Innere Medizin IV, Hämatologie / Onkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Gebaeude N19 27, Martinistrasse 52, Hamburg
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Salamanca
Hematology, 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 |
|---|---|---|---|---|---|
| Germany | 2023-11-10 | ||||
| Spain | 2023-11-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-90068
- Halt date
- 2025-06-26
- Member states concerned
- Germany
- Publication date
- 2025-07-10
- Reason
- Study management related
- Explanation
- Please be informed that the attached memorandum has been sent to the investigators, informing them of the “Formal Notification of Study Enrollment Pause” for the CA055-001 study until further notice. This decision follows the release from our post-marketing commitment by the U.S. Food and Drug Administration (FDA) and is not related to any safety issue or finding, marking a significant milestone in the study’s lifecycle. Following the FDA response, we are now negotiating release of further post-marketing commitments in other countries, such releases expected by year-end.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-90067
- Halt date
- 2025-06-26
- Member states concerned
- Spain
- Publication date
- 2025-07-10
- Reason
- Study management related
- Explanation
- Please be informed that the attached memorandum has been sent to the investigators, informing them of the “Formal Notification of Study Enrollment Pause” for the CA055-001 study until further notice. This decision follows the release from our post-marketing commitment by the U.S. Food and Drug Administration (FDA) and is not related to any safety issue or finding, marking a significant milestone in the study’s lifecycle. Following the FDA response, we are now negotiating release of further post-marketing commitments in other countries, such releases expected by year-end.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-12 | Germany | Acceptable 2023-08-24
|
2023-08-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-09 | Germany | Acceptable 2023-11-16
|
2023-11-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-11 | Germany | Acceptable 2024-08-15
|
2024-08-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-10 | Germany | Acceptable 2024-08-15
|
2024-10-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-22 | Germany | Acceptable 2025-10-01
|
2025-10-02 |