Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
274
Countries
4
Sites
10
Richter's Syndrome
Key facts
- Sponsor
- Prelude Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Oct 2023 → 22 Jan 2026
- Decision date (initial)
- 2023-09-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502672-23-00
- ClinicalTrials.gov
- NCT05665530
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Richter's Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066481 | Hematological malignancy | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Prelude Therapeutics Inc.
- Sponsor organisation
- Prelude Therapeutics Inc.
- Address
- 200 Powder Mill Road
- City
- Wilmington
- Postcode
- 19803-2907
- Country
- United States
Scientific contact point
- Organisation
- Prelude Therapeutics Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Prelude Therapeutics Inc.
- Contact name
- General Contact
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 40 | 4 |
| Germany | Ended | 12 | 2 |
| Italy | Ended | 45 | 3 |
| Poland | Ended | 12 | 1 |
| Rest of world
Switzerland, United States, United Kingdom, Canada, Australia, Korea, Republic of
|
— | 165 | — |
Investigational sites
Institut Curie
Service D'oncologie Médicale, 35 Rue Dailly, 92210, Saint-Cloud
Centre Hospitalier Universitaire De Lille
Hematology, Rue Michel Polonowski, 59000, Lille
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Assistance Publique Hopitaux De Paris
Unité Hémopathies Lymphoïdes, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Technische Universitaet Dresden
NCT/UCC ECTU, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Unità Clinica di Fase, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Unita Sanitaria Locale Della Romagna
Unità Clinica di Fase I Ematologia di Ravenna c/o UO Ematologia di Ravenna, Viale Vincenzo Randi 5, 48121, Ravenna
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 | 2023-11-23 | 2025-03-26 | 2023-11-29 | 2024-12-18 | |
| Germany | 2024-02-18 | 2025-02-18 | 2024-03-12 | 2024-12-18 | |
| Italy | 2023-10-18 | 2025-03-19 | 2024-02-16 | 2025-01-16 | |
| Poland | 2023-10-26 | 2026-01-21 | 2024-01-16 | 2024-12-30 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-17 | Italy | Acceptable 2023-09-11
|
2023-09-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-15 | Italy | Acceptable 2024-03-12
|
2024-03-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-14 | Italy | Acceptable 2024-08-30
|
2024-08-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-10 | Italy | Acceptable 2024-08-30
|
2024-09-10 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-12 | Italy | Acceptable 2024-08-30
|
2024-09-12 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-12 | Italy | Acceptable 2024-08-30
|
2024-09-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-09-12 | Acceptable | 2024-10-16 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-09-12 | Acceptable | 2024-11-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-09-12 | Acceptable | 2024-09-17 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-11-13 | Italy | Acceptable | 2024-11-13 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-02 | Italy | Acceptable 2025-01-27
|
2025-01-27 |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-04-04 | Acceptable 2025-05-15
|
2025-05-25 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-07-29 | Italy | Acceptable 2025-05-15
|
2025-07-29 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-10-03 | Italy | Acceptable 2025-05-15
|
2025-10-03 |