An Open-Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring

Start 30 Dec 2024 · Status Ongoing, recruiting · 5 EU/EEA countries · 20 sites · Protocol PLATFORMPACAN1001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ongoing, recruiting

Participants planned 117

Countries 5

Sites 20

Non-Hodgkin lymphoma and chronic lymphocytic leukemia

Key facts

Sponsor: Janssen Cilag International
Participant type: Patients
Age range: 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 30 Dec 2024 → ongoing
Decision date (initial): 2024-12-18
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

Non-Hodgkin lymphoma and chronic lymphocytic leukemia

Version	Level	Code	Term	System organ class
23.1	LLT	10084346	B-cell non-Hodgkin´s lymphoma	100000004848
21.0	LLT	10008976	Chronic lymphocytic leukemia	10029104

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation: Janssen Cilag International
Address: Turnhoutseweg 30
City: Beerse
Postcode: 2340
Country: Belgium

Scientific contact point

Organisation: Janssen Cilag International
Contact name: CTIS Point of Contact

Public contact point

Organisation: Janssen Cilag International
Contact name: CTIS Point of Contact

Locations

5 EU/EEA countries · 20 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	1	1
France	Ongoing, recruiting	5	6
Greece	Ongoing, recruiting	1	1
Poland	Ongoing, recruiting	30	4
Spain	Ongoing, recruiting	15	8
Rest of world Australia, Georgia, Israel, United States, Japan, Moldova, Republic of, Korea, Republic of, Taiwan, Ukraine, United Kingdom	—	65	—

Investigational sites

Belgium

1 site · Ongoing, recruiting

Universitair Ziekenhuis Gent

Hematology, Corneel Heymanslaan 10, 9000, Gent

France

6 sites · Ongoing, recruiting

Centre Hospitalier Universitaire De Lille

Hopital Claude Huriez - Service des Maladies du sang, Rue Michel Polonowski, 59000, Lille

Institut Paoli Calmettes

Hematology Department, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille

Centre Hospitalier Universitaire De Nantes

Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes

Institut Gustave Roussy

Département d’Innovations Thérapeutiques et d’essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif

Institut Curie

Unité d’Investigation Clinique Adulte, 26 Rue D Ulm, 75005, Paris

Oncopole Claudius Regaud

Institut Universitaire du Cancer I.U.C.Toulouse – Oncopôle Département Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse

Greece

1 site · Ongoing, recruiting

General Hospital Of Athens Alexandra

Department of Clinical Therapeutics, Vassilissis Sofias Avenue 80, 115 28, Athens

Poland

4 sites · Ongoing, recruiting

Pratia S.A.

Pratia MCM, Ul. Pana Tadeusza 2, 30-727, Cracow

Pratia Hematologia Sp. z o.o.

Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice

Uniwersyteckie Centrum Kliniczne

Osrodek Badan Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk

Aidport Sp. z o.o.

Aidport Sp z o o, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo

Spain

8 sites · Ongoing, recruiting

Clinica Universidad De Navarra

Hematology Department, Pio XII Etorbidea 36, 31008, Pamplona

Clinica Universidad De Navarra

Hematology Department, Pio XII Etorbidea 36, 31008, Pamplona

Hospital Clinic De Barcelona

Hematology Department, Calle Villarroel 170, 08036, Barcelona

Hospital Universitario 12 De Octubre

Hematology Department, Avenida De Cordoba Sn, 28041, Madrid

Hospital Universitario De Salamanca

Hematology Department, Paseo De San Vicente 58-182, 37007, Salamanca

Hospital Universitari Vall D Hebron

Oncology department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Hospital Universitario Fundacion Jimenez Diaz

Oncology department, Avenida De Los Reyes Catolicos 2, 28040, Madrid