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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 rollover study focused on tracking serious side effects and severe adverse events, what does that tell us about how much is still unknown about the safety of the treatment I'd be continuing?
2This trial is 'enrolling by invitation only,' which means I would need to have been in a prior related study — can you help me understand whether my participation in a previous trial actually makes me eligible to roll over into this one?
3Because the main thing being measured here is the number of participants experiencing serious or Grade 3 and higher adverse events, what kinds of serious side effects have already been observed in the earlier study that fed into this rollover?
4Given that this is still a Phase 1 study focused on safety monitoring rather than proving the treatment works, is there a standard-of-care treatment option for my specific diagnosis — whether that's AML, CLL, non-Hodgkin lymphoma, MDS, or castration-resistant prostate cancer — that might offer more established evidence of benefit right now?
5What ongoing safety monitoring would be required of me if I joined this rollover study, and how might the time commitment and follow-up visits affect my day-to-day life compared to continuing treatment outside of a trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Serious Adverse Events (SAEs) and Grade Greater than or equals to (>=) 3 Related Adverse Events (AEs)
Timeframe: Up to approximately 3 years and 7 months