NCT06788509Enrolling by invitationPhase 1
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 16 Jan 2025
- Start date
- 30 Dec 2024
- Primary completion date
- 19 Jan 2028
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Prostate cancer, Hodgkin lymphoma, Chronic myeloid leukaemia, Myelodysplastic syndromes, Chronic lymphocytic leukaemia, Acute myeloid leukemia
- NCT number
- NCT06788509
- EU CT number
- 2024-515457-21-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 120
- From 30 Dec 2024 to the primary completion date, 19 Jan 2028
- 42 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
- Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA
Other
- Meets any exclusion criteria within the pertinent ISA
Who the study is looking for
- Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study
- Satisfy all ISA specific inclusion criteria
- Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA
- Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Macquarie University Hospital Coordinator of this site? Confirm its status | Macquarie University | Australia | Unknown status |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Linear Clinical Research Ltd Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Scientia Clinical Research Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Not yet recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| St Bartholomews Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University Hospitals Plymouth NHS Trust Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Med.Center - Hematology Institute Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah University Hospita Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| National Hospital Organization Nagoya Medical Center Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| ARENSIA Exploratory Medicine Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Chang Kung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Medical Center of Limited Liability Company Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.