Siltuximab in Large Granular Lymphocytic Leukemia (LGLL) (NCT05316116) | Clinical Trial Compass
TerminatedEarly Phase 1
Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)
Stopped: lack of efficacy/futility
United States6 participantsStarted 2023-02-15
Plain-language summary
The purpose of the study is to evaluate the safety and effectiveness of siltuximab for participants being treated for large granular lymphocytic leukemia (LGLL).
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
. severe neutropenia less than 500/mm³, OR
. neutropenia associated with recurrent infection, OR
. symptomatic anemia with Hemoglobin \< 9 g/dL, OR
. transfusion-dependent anemia with transfusion needs \>= 1 u per month, OR
. severe thrombocytopenia \<20,000/mm³, OR
. thrombocytopenia \<50,000/mm³ with bleeding.
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.
1This trial for Large Granular Lymphocytic Leukemia was terminated early — can you find out why it was stopped, and what that means for the safety or usefulness of siltuximab as a treatment option for me?
2Since this was an early Phase 1 trial measuring overall response rate, how much do we actually know about whether siltuximab works for LGLL, and is there enough data from this study to inform my treatment decisions at all?
3Are there other active clinical trials for LGLL that I might be worth discussing as an alternative, now that this siltuximab study is no longer enrolling?
4Given that this trial is terminated, would standard treatments for LGLL — like methotrexate or cyclosporine — be a more appropriate starting point for my situation right now?
5Is there any published or preliminary data from this trial that you could review with me, so we can understand what was learned about siltuximab before it was stopped?
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
Overall Response Rate
Timeframe: Up to 30 months
Trial details
NCT IDNCT05316116
SponsorH. Lee Moffitt Cancer Center and Research Institute