Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
30
Countries
3
Sites
13
Relapsed/Refractory DLBCL
Key facts
- Sponsor
- Karyopharm Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Jun 2016 → ongoing
- Decision date (initial)
- 2024-09-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512115-50-00
- EudraCT number
- 2014-001977-15
- ISRCTN
- ISRCTN02227251
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory DLBCL
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karyopharm Therapeutics Inc.
- Sponsor organisation
- Karyopharm Therapeutics Inc.
- Address
- 85 Wells Avenue
- City
- Newton
- Postcode
- 02459-3298
- Country
- United States
Scientific contact point
- Organisation
- Karyopharm Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Public contact point
- Organisation
- Karyopharm Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Locations
3 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ongoing, recruitment ended | 10 | 5 |
| Italy | Ongoing, recruitment ended | 10 | 5 |
| Poland | Ongoing, recruitment ended | 10 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
University General Hospital Attikon
B’ Department of Internal Medicine Propaedeutic, Haematology Division, Rimini Street 1, 124 62, Athens
University General Hospital Of Ioannina
Department of Clinical Hematology, Niarchou Stavrou Avenue, 455 00, Ioannina
Laiko General Hospital Of Athens
Hematology Clinic, Agiou Thoma (goudi) 17, 115 27, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Of Haematology, Haematopoietic Cell Transplantation Centre, Exochi, 570 10, Thessaloniki
General Hospital Of Athens G Gennimatas
Hematology Clinic, Messogion Avenue 154, 115 27, Athens
Azienda Ospedaliera Universitaria Senese
hematology, Viale Mario Bracci 1, 53100, Siena
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hematology, Largo Francesco Vito 1, 00168, Rome
Careggi University Hospital
Hematology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Istituto Nazionale Tumori Fondazione Pascale
homatology, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Oncology, Corso Giuseppe Mazzini 18, 28100, Novara
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Wojewodzki Szpital Specjalistyczny W Legnicy
Oddział Hematologii, Ul. Jaroslawa Iwaszkiewicza 5, 59-220, Legnica
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 | 2018-05-18 | 2018-05-25 | 2026-04-24 | ||
| Italy | 2016-11-28 | 2016-12-19 | 2026-04-24 | ||
| Poland | 2016-06-22 | 2016-08-30 | 2026-04-24 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Poland | Acceptable 2024-06-19
|
2024-06-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-06 | Poland | Acceptable 2025-03-31
|
2025-04-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-08 | Poland | Acceptable 2025-03-31
|
2025-10-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-24 | Poland | Acceptable 2026-04-17
|
2026-04-17 |