Clinical trial • Phase I • Oncology
JNJ-88998377 for Relapsed or refractory B-cell non-Hodgkin lymphoma
Phase I trial of JNJ-88998377 for Relapsed or refractory B-cell non-Hodgkin lymphoma. adaptive. 130 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory B-cell non-Hodgkin lymphoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 13-03-2024
- First CTIS Authorization Date
- 03-07-2024
Trial design
adaptive Phase I trial across 4 sites in Italy, Poland.
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 130
Eligibility
Recruits 130 Vulnerable population selected; no details provided on consent or assent handling in the available documents..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling in the available documents.
Recruitment
- Planned Sample Size
- 130
- Recruitment Window Months
- 43
- Consent Approach
- Not specified in the available documents. Vulnerable population selected but informed consent/assent process and language details are not provided.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 30
Italy
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 545
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UO Ematologia
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
Poland
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 530
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Hematologii i Transplantacji Szpiku
- Contact Person Name
- Pawel Steckiewicz
- Contact Person Email
- p.steckiewicz@gmail.com
- Site Name
- Pratia Hematologia Sp. z o.o.
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- sebastian.grosicki@pratia.com
- Site Name
- Aidport Sp. z o.o.
- Contact Person Name
- Michal Kwiatek
- Contact Person Email
- michal.kwiatek@aidport.pl
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-88998377
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