Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
218
Countries
4
Sites
19
Relapsed or Refractory Acute Myeloid Leukemia (AML)
Key facts
- Sponsor
- Aptose Biosciences Inc.
- 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
- 11 Aug 2023 → 19 Sep 2024
- Decision date (initial)
- 2023-06-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503244-14-00
- ClinicalTrials.gov
- NCT03850574
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or Refractory Acute Myeloid Leukemia (AML)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
| 21.1 | PT | 10081513 | Acute myeloid leukaemia refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aptose Biosciences Inc.
- Sponsor organisation
- Aptose Biosciences Inc.
- Address
- 12770 High Bluff Drive Suite 120
- City
- San Diego
- Postcode
- 92130-2058
- Country
- United States
Scientific contact point
- Organisation
- Aptose Biosciences Inc.
- Contact name
- Zoey Liu-Imanuel
Public contact point
- Organisation
- Aptose Biosciences Inc.
- Contact name
- Zoey Liu-Imanuel
Locations
4 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 25 | 3 |
| Poland | Ended | 8 | 4 |
| Spain | Ended | 64 | 11 |
| Sweden | Ended | 6 | 1 |
| Rest of world
Australia, Korea, Republic of, Canada, United States, Taiwan, New Zealand, United Kingdom
|
— | 115 | — |
Investigational sites
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik m.S. Haematologie, Onkologie und Tumorimmunologie CVK Campus Virchow-Klinikum, Augustenburger Platz 1, Wedding, Berlin
Staedtisches Klinikum Braunschweig gGmbH
Medizinische Klinik III, Klinik fuer Haematologie und Onkologie, Celler Strasse 38, 38114, Brunswick
University Of Leipzig
Klinik, Poliklinik, fuer Haematologie, Zelltherapie-Haemostaseologie Bereich Haematologie-Zelltherap, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Instytut Hematologii I Transfuzjologii
Instytut Hematologii i Transfuzjologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
SPZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Hematologii, Ul. Mikolaja Kopernika 17, 31-501, Cracow
Szpitale Pomorskie Sp. z o.o.
Szpitale Pomorskie Sp. z o.o. Oddział Hematologii i Transplantologii Szpiku, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital De La Santa Creu I Sant Pau
Hematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Hematology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital General Universitario De Alicante
Hematology, ª Centro De Diagnosticos, Avinguda Del Pintor Baeza 12, Alicante
Hospital Universitario Central De Asturias
Hematology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
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 | 2023-10-09 | 2024-06-06 | 2023-10-18 | ||
| Spain | 2023-08-11 | 2024-09-19 | 2023-08-28 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-24 | Sweden | Acceptable 2023-06-12
|
2023-06-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-30 | Sweden | Acceptable 2023-06-12
|
2023-08-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-21 | Acceptable 2023-06-12
|
2024-03-21 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-08-28 | Sweden | Acceptable 2023-06-12
|
2024-08-28 |