An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial (NCT03844048) | Clinical Trial Compass
Active — Not RecruitingPhase 3
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
United States, Australia, Austria165 participantsStarted 2019-09-06
Plain-language summary
The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.
Who can participate
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:
* Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
* Male subject agrees to refrain from sperm donation.
* Female subjects must not be pregnant or breastfeeding.
Exclusion Criteria:
\- None.
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 an extension study specifically for people who have already completed a prior venetoclax trial, can you help me understand whether my treatment history makes me eligible to even be considered for this kind of continuation study?
2Given that the main thing being measured here is adverse events — meaning side effects and safety — what does that tell us about what is still being learned about venetoclax's long-term safety profile, and how should that factor into our decision?
3Since this study is active but no longer recruiting new participants, is there any realistic chance I could still be enrolled, or should we focus our energy on other venetoclax trials or standard treatment options instead?
4My diagnosis is one of several conditions covered by this trial, including CLL, AML, multiple myeloma, or lymphoma — does the safety and benefit data from venetoclax look different depending on which condition I have, and how does that affect what you'd recommend for me?
5If I'm not able to join this extension study, are there other ongoing Phase 3 venetoclax trials or established standard-of-care treatments you think I should consider instead?
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 Adverse Events
Timeframe: From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).