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A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

NCT06788509

Enrolling By InvitationPhase 1

Sponsor: Janssen Research & Development, LLC

Conditions: Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Neoplasms

Interventions: JNJ-75348780, JNJ-67856633, JNJ-54179060, JNJ-64264681, JNJ-74856665

Countries: Australia, Belgium, France, Georgia, Greece, Israel, Japan, Moldova

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).

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Meets any exclusion criteria within the pertinent ISA
Locations (36)
  • Macquarie University, Australia
  • Nedlands, Australia
  • Randwick, Australia
  • Ghent, Belgium
  • Lille, France
  • Nantes, France
  • Villejuif, France
  • Tbilisi, Georgia
  • Athens, Greece
  • Haifa, Israel
  • Haifa, Israel
  • Haifa, Israel
  • Jerusalem, Israel
  • Tel Aviv, Israel
  • Nagoya, Japan
  • Tokyo, Japan
  • Chisinau, Moldova
  • Gdansk, Poland
  • Krakow, Poland
  • Skorzewo, Poland
  • Seoul, South Korea
  • Barcelona, Spain
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Pamplona, Spain
  • Salamanca, Spain
  • Kaohsiung City, Taiwan
  • Taichung, Taiwan
  • + 6 more on CT.gov