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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
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

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Macquarie University Hospital
Coordinator of this site? Confirm its status
Macquarie UniversityAustraliaUnknown status
The Alfred Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Linear Clinical Research Ltd
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Scientia Clinical Research
Coordinator of this site? Confirm its status
RandwickAustraliaUnknown status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
Rigshospitalet
Coordinator of this site? Confirm its status
Copenhagen OeDenmarkNot yet recruiting
Odense University Hospital
Coordinator of this site? Confirm its status
Odense CDenmarkNot yet recruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Institut Curie
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ParisFranceRecruiting
Oncopole Claudius Regaud
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ToulouseFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
University Hospitals of Leicester NHS Trust
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LeicesterUnited KingdomUnknown status
St Bartholomews Hospital
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LondonUnited KingdomUnknown status
University Hospitals Plymouth NHS Trust
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PlymouthUnited KingdomUnknown status
Arensia Exploratory Medicine
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TbilisiGeorgiaUnknown status
General Hospital of Athens - Alexandra
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AthensGreeceRecruiting
Carmel Medical Center
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HaifaIsraelUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Rambam Med.Center - Hematology Institute
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HaifaIsraelUnknown status
Hadassah University Hospita Ein Kerem
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JerusalemIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
National Hospital Organization Nagoya Medical Center
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NagoyaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
ARENSIA Exploratory Medicine
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ChisinauMoldovaUnknown status
Pratia S.A.
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CracowPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Chang Kung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Coordinator of this site? Confirm its status
KyivUkraineUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.