Overview
Sponsor-declared trial summary
Mature B-Cell Neoplasm, Non-Hodgkin Lymphoma, Diffuse large B-cell lymphoma (DLBCL), Waldenstrom Macroglobulinemia, MALT Lymphoma, Follicular Lymphoma, Pediatric-Type Follicular Lymphoma, Large B-cell lymphoma with IRF4 rearrangement, Epstein-Barr virus (EBCV)–positive diffuse large B-cell lymphoma (DLBCL), Nos, Burkitt's Lymphoma, Plasmablastic Lymphoma, High-grade B-cell Lymphoma, Primary Cutaneous Follicle Center Lymphoma, Primary Effusion Lymphoma, Mantle Cell Lymphoma, Diffuse large B-cell lymphoma (DLBCL) Germinal Center B-Cell Type, Primary Mediastinal Large B Cell Lymphoma, T-Cell/Histiocyte-Rich Lymphoma, ALK-Positive Large B-Cell Lymphoma, Primary Cutaneous Diffuse Large B-Cell Lymphoma (DLBCL), Splenic Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Nodal Marginal Zone Lymphoma, HHV8-Positive Diffuse large B-cell lymphoma (DLBCL), Nos Lymphoplasmacytic Lymphoma, Duodenal-Type Follicular Lymphoma
Key facts
- Sponsor
- Schrodinger Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Dec 2024 → ongoing
- Decision date (initial)
- 2024-01-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505204-34-00
- ClinicalTrials.gov
- NCT05544019
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Mature B-Cell Neoplasm, Non-Hodgkin Lymphoma, Diffuse large B-cell lymphoma (DLBCL), Waldenstrom Macroglobulinemia, MALT Lymphoma, Follicular Lymphoma, Pediatric-Type Follicular Lymphoma, Large B-cell lymphoma with IRF4 rearrangement, Epstein-Barr virus (EBCV)–positive diffuse large B-cell lymphoma (DLBCL), Nos, Burkitt's Lymphoma, Plasmablastic Lymphoma, High-grade B-cell Lymphoma, Primary Cutaneous Follicle Center Lymphoma, Primary Effusion Lymphoma, Mantle Cell Lymphoma, Diffuse large B-cell lymphoma (DLBCL) Germinal Center B-Cell Type, Primary Mediastinal Large B Cell Lymphoma, T-Cell/Histiocyte-Rich Lymphoma, ALK-Positive Large B-Cell Lymphoma, Primary Cutaneous Diffuse Large B-Cell Lymphoma (DLBCL), Splenic Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Nodal Marginal Zone Lymphoma, HHV8-Positive Diffuse large B-cell lymphoma (DLBCL), Nos Lymphoplasmacytic Lymphoma, Duodenal-Type Follicular Lymphoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Schrodinger Inc.
- Sponsor organisation
- Schrodinger Inc.
- Address
- 1540 Broadway Floor 24th
- City
- New York
- Postcode
- 10036-4039
- Country
- United States
Scientific contact point
- Organisation
- Schrodinger Inc.
- Contact name
- Karine Cadren
Public contact point
- Organisation
- Schrodinger Inc.
- Contact name
- Karine Cadren
Locations
5 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 9 | 2 |
| Italy | Ongoing, recruiting | 10 | 6 |
| Poland | Ongoing, recruiting | 3 | 3 |
| Romania | Ongoing, recruiting | 7 | 2 |
| Spain | Ongoing, recruiting | 5 | 7 |
| Rest of world
United States, Moldova, Republic of, Ukraine
|
— | 64 | — |
Investigational sites
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 | 2025-02-12 | 2025-04-03 | |||
| Italy | 2025-01-27 | 2025-03-18 | |||
| Poland | 2024-12-30 | 2025-01-29 | |||
| Romania | 2025-01-09 | 2025-01-17 | |||
| Spain | 2025-01-31 | 2025-09-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-01-08
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with the version 6.4 of CTR Q&A / point 1.23, the sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-02 | Spain | Acceptable with conditions 2023-09-25
|
2023-09-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-17 | Spain | Acceptable 2024-02-05
|
2024-01-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-14 | Acceptable | 2024-05-03 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-09 | Spain | Acceptable 2024-12-12
|
2024-12-12 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-09 | Acceptable 2024-12-12
|
2025-01-09 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-07 | Spain | Acceptable 2025-08-11
|
2025-08-11 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-04 | Spain | Acceptable 2025-08-11
|
2025-09-04 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-31 | Spain | Acceptable 2025-08-11
|
2025-10-31 |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-03 | Spain | Acceptable 2026-05-11
|
2026-05-11 |