Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
54
Countries
1
Sites
5
Relapsed and/or refractory acute lymphoblastic (ALL) or myeloid (AML) leukemia in patients who are not eligible for curative therapies and lack other available therapeutic options
Key facts
- Sponsor
- Instytut Hematologii I Transfuzjologii
- 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
- 28 Jan 2022 → ongoing
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518301-18-00
- EudraCT number
- 2020-004926-49
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and/or refractory acute lymphoblastic (ALL) or myeloid (AML) leukemia in patients who are not eligible for curative therapies and lack other available therapeutic options
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instytut Hematologii I Transfuzjologii
- Sponsor organisation
- Instytut Hematologii I Transfuzjologii
- Address
- Ul Indiry Gandhi 14
- City
- Warsaw
- Postcode
- 02-776
- Country
- Poland
Scientific contact point
- Organisation
- Instytut Hematologii I Transfuzjologii
- Contact name
- Director of the Institute
Public contact point
- Organisation
- Instytut Hematologii I Transfuzjologii
- Contact name
- Director of the Institute
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 54 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Samodzielny Publiczny Szpital Kliniczny Im.Adrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
Klinika Hematologii i Transplantacji Szpiku, Oddzial Hematologii i Transplantacji Szpiku, Ul. Henryka Dąbrowskiego 25, Katowice
Instytut Hematologii I Transfuzjologii
Instytut Hematologii i Transfuzjologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersytet Medyczny we Wrocławiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Pasteura 4, 50-367, Wrocław
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytet Medyczny w Poznaniu
Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego, Szamarzewskiego 82/84, Poland, Poznan
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 |
|---|---|---|---|---|---|
| Poland | 2022-01-28 | 2022-01-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-17 | Poland | Acceptable 2024-12-09
|
2024-12-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-18 | Poland | Acceptable 2024-12-09
|
2025-12-18 |