Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
97
Countries
2
Sites
11
Acute Myeloid Leukemia (AML) with Measurable Residual Disease (MRD)
Key facts
- Sponsor
- Florentine Cullinan Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jan 2024 → ongoing
- Decision date (initial)
- 2023-11-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia (AML) with Measurable Residual Disease (MRD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Florentine Cullinan Corp.
- Sponsor organisation
- Florentine Cullinan Corp.
- Address
- 1 Main Street Suite 520
- City
- Cambridge
- Postcode
- 02142-1531
- Country
- United States
Scientific contact point
- Organisation
- Florentine Cullinan Corp.
- Contact name
- Study Responsible Physician
Public contact point
- Organisation
- Florentine Cullinan Corp.
- Contact name
- Study Responsible Physician
Locations
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 70 | 5 |
| Spain | Ongoing, recruiting | 27 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Leipzig AöR
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Innere Medizin III Hämatologie und Internistische Onkologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Tuebingen AöR
Exzellenzcluster iFIT (EXC 2180) Peptid-basierte Immuntherapie KKE Translationale Immunologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Clinica Universidad De Navarra
Hematology and hemotherapy, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Hematology and hemotherapy, Calle Marquesado De Santa Marta 1, 28027, Madrid
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 | 2024-01-12 | 2024-02-14 | |||
| Spain | 2024-10-04 | 2024-10-10 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-10 | Germany | Acceptable 2023-11-16
|
2023-11-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-23 | Germany | Acceptable | 2023-12-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-04 | Germany | Acceptable | 2024-01-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-19 | Germany | Acceptable 2024-06-20
|
2024-06-24 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-06-26 | Acceptable 2023-11-16
|
2024-09-23 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-03 | Germany | Acceptable | 2024-07-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-24 | Germany | Acceptable 2024-12-09
|
2024-12-13 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-10 | Germany | Acceptable | 2025-06-10 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-24 | Germany | Acceptable 2026-01-14
|
2026-01-14 |