Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
219
Countries
3
Sites
12
Newly diagnosed aggressive B-cell lymphoma (a-BCL)
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 17 Sep 2021 → ongoing
- Decision date (initial)
- 2023-10-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506094-35-00
- EudraCT number
- 2020-005705-71
- WHO UTN
- U1111-1264-4203
- ClinicalTrials.gov
- NCT04884035
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Newly diagnosed aggressive B-cell lymphoma (a-BCL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10080217 | High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements | 10029104 |
| 21.0 | LLT | 10023699 | Large B-cell lymphoma subtype primary mediastinal (Thymic) large B-cell lymphoma | 10029104 |
| 21.1 | LLT | 10065863 | Anaplastic large-cell lymphoma primary cutaneous type | 10029104 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 23.0 | PT | 10071977 | Anaplastic lymphoma kinase gene mutation | 100000004850 |
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
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Temporarily halted | 50 | 4 |
| Poland | Temporarily halted | 50 | 5 |
| Spain | Ongoing, recruitment ended | 12 | 3 |
| Rest of world
United States, Australia, Korea, Republic of, Taiwan
|
— | 107 | — |
Investigational sites
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Propaedeutic Internal Medicine Department of NKUA, Rimini 1, 124 61, Chaidari
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department and Bone Marrow Transplantation Unit, Exochi, 570 10, Thessaloniki
Laiko General Hospital Of Athens
Hematology Clinic and Bone Marrow Transplantation Unit, Sevastoupoleos 16, 115 26, Athens
Evangelismos S.A.
Hematology and Lymphoma Department, Ipsiladou 45-47, 106 76, Athens
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Hematologii i Chorób Wewnętrznych wraz z Poradnią Hematologiczną, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Pratia S.A.
N/A, Ul. Pana Tadeusza 2, 30-727, Cracow
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Hospital Universitario Virgen De La Victoria
Oncology Service, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Germans Trias I Pujol
Haematology Service, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario De Salamanca
Haematology Service, 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 |
|---|---|---|---|---|---|
| Greece | 2022-09-07 | 2022-09-12 | 2026-02-04 | ||
| Poland | 2022-05-31 | 2022-08-29 | 2026-02-04 | ||
| Spain | 2021-09-17 | 2022-02-02 | 2024-05-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-119177
- Halt date
- 2026-02-03
- Member states concerned
- Poland
- Publication date
- 2026-02-18
- Reason
- Sponsor decision
- Explanation
- Drug supply constraints due to fast enrollment
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-119178
- Halt date
- 2026-02-03
- Member states concerned
- Greece
- Publication date
- 2026-02-18
- Reason
- Sponsor decision
- Explanation
- Drug supply constraints due to fast enrollment
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-18 | Spain | Acceptable 2023-09-15
|
2023-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-24 | Spain | Acceptable 2024-08-16
|
2024-08-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | Acceptable | 2025-02-17 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-30 | Spain | Acceptable | 2025-05-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-04 | Spain | Acceptable 2025-09-08
|
2025-09-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-19 | Spain | Acceptable 2026-04-10
|
2026-04-13 |