Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
220
Countries
1
Sites
3
Advanced lymphomas (classic Hodgkin lymphoma [cHL], peripheral T cell lymphoma [PTCL], and diffuse large B cell lymphoma [DLBCL])
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 May 2025 → 24 Apr 2026
- Decision date (initial)
- 2025-04-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced lymphomas (classic Hodgkin lymphoma [cHL], peripheral T cell lymphoma [PTCL], and diffuse large B cell lymphoma [DLBCL])
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10025648 | Malignant mast cell tumors unspecified site extranodal and solid organ sites | 10029104 |
| 20.0 | LLT | 10020328 | Hodgkin's lymphoma | 10029104 |
| 21.0 | PT | 10012825 | Diffuse large B-cell lymphoma stage III | 100000004864 |
| 26.0 | PT | 10034629 | Peripheral T-cell lymphoma unspecified stage III | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 33 | 3 |
| Rest of world
United States
|
— | 187 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 |
|---|---|---|---|---|---|
| Spain | 2025-05-28 | 2025-06-03 | 2025-08-27 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-28 | Spain | Acceptable 2025-04-21
|
2025-04-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-15 | Spain | Acceptable | 2025-08-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-12 | Spain | Acceptable | 2025-12-12 |