A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jan 17, 2025

Keywords

ClinConnect Summary

This study is a long-term safety check for people with certain blood cancers and some advanced solid tumors who have already participated in Janssen cancer studies. It’s an open-label, single-group platform study, meaning everyone knows what treatment they’re getting and there’s no comparison group. Participants will continue to receive the same study drugs (the ones they were taking in their parent studies) at the same doses, so researchers can watch for long-term safety issues over several years. The study is sponsored by Janssen and is taking place at many centers around the world.

Who can join and what to expect: Adults 18 and older of any sex who previously took part in a related parent study and signed consent, and who are willing to follow the study rules, can be invited. People are excluded if a health problem or condition makes participation risky or could cloud the results, or if they have unacceptable side effects or cancer progression when rolling over to this study. The main goal is to track serious side effects and other significant adverse events over about 3.5 years. The trial also plans to share de-identified study data with researchers in the future under privacy safeguards. Enrollment is by invitation and the study is expected to run through 2028.

Gender

ALL

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