Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
219
Countries
4
Sites
24
Chronic Myeloid Leukemia
Key facts
- Sponsor
- Terns Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 May 2024 → ongoing
- Decision date (initial)
- 2024-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507677-18-00
- ClinicalTrials.gov
- NCT06163430
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10009700 | CML | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Terns Inc.
- Sponsor organisation
- Terns Inc.
- Address
- 1065 East Hillsdale Boulevard Suite 100
- City
- Foster City
- Postcode
- 94404-1688
- Country
- United States
Scientific contact point
- Organisation
- Terns Inc.
- Contact name
- Leanne Holes
Public contact point
- Organisation
- Terns Inc.
- Contact name
- Study Director
Locations
4 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 26 | 6 |
| Germany | Ongoing, recruiting | 25 | 7 |
| Italy | Ongoing, recruiting | 12 | 3 |
| Spain | Ongoing, recruiting | 40 | 8 |
| Rest of world
New Zealand, United States, Australia, India, United Kingdom, Korea, Republic of, Canada
|
— | 116 | — |
Investigational sites
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Hematology Department, 229 Cours De L Argonne, 33000, Bordeaux
Hopital Saint Louis
Division of Hematology and Immunology Adult Hematology Department and Apheresis Unit, 1 Avenue Claude Vellefaux, 75010, Paris
Hospital Hotel Dieu
Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Lyon Sud
Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Paoli-Calmettes
Hematology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Klinikum rechts der Isar der TU Muenchen AöR
N/AKlinik und Poliklinik für Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitat Heidelberg
III. Medizinische Klinik , Hämatologie und Internistische Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Aachen AöR
Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Pauwelsstrasse 30, 52074, Aachen
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik m. S. Hämatologie und Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Goethe University Frankfurt
Medizinische Klinik II Hämatologie/Onkologie Studienzentrale, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Medizinische Hochschule Hannover
Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II Abt. Hämatologie / Onkologie, Am Klinikum 1, Lobeda, Jena
Fondazione IRCCS San Gerardo Dei Tintori
SC Ematologia Adulti, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
SC Ematologia, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento di Malattie Oncologiche edEmatologiche, Via Pietro Albertoni 15, 40138, Bologna
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Quironsalud Zaragoza
Hematology, Paseo Renovales S/n, 50006, Zaragoza
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario De La Princesa
Hematology, Calle De Diego De Leon 62, 28006, Madrid
El Hospital Universitario De Gran Canaria Dr. Negrin
Hematology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 |
|---|---|---|---|---|---|
| France | 2024-10-28 | 2024-10-28 | |||
| Germany | 2024-09-11 | 2024-09-11 | |||
| Italy | 2024-07-17 | 2024-07-17 | |||
| Spain | 2024-05-17 | 2024-05-17 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-20 | Spain | Acceptable 2024-04-22
|
2024-04-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-03 | Acceptable | 2024-07-22 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-17 | Spain | Acceptable 2025-03-13
|
2025-03-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-25 | Acceptable | 2025-04-02 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-25 | Acceptable | 2025-04-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-26 | Acceptable | 2025-04-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-27 | Spain | Acceptable | 2025-04-14 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-09 | Spain | Acceptable 2025-09-05
|
2025-09-05 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-18 | Spain | Acceptable 2026-05-25
|
2026-05-26 |