A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL) (NCT03494179) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)
China106 participantsStarted 2018-04-02
Plain-language summary
The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022.
Who can participate
Age range
18 Years – 75 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
. Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelet count ≥ 75×109/L, independent of growth factor support within 7 days of the first dose with study drug, Hemoglobin ≥ 80 g/L; ANC ≥ 1.0×109/L, Platelet count ≥ 50×109/L if bone marrow involvement
. Total bilirubin ≤ 2× ULN; AST or ALT ≤ 2.5 ULN; Creatinine clearance ≥ 30ml/min; Amylase ≤ ULN and Lipase ≤ ULN
. International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN
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 studied ICP-022 in relapsed or refractory mantle cell lymphoma — since it's now completed, can you tell me what the overall response rate results showed, and what that might mean for someone in my situation?
2Because this was a Phase 1/Phase 2 study, the safety profile may still be evolving — what side effects were observed with ICP-022, and how do they compare to other treatments I might consider?
3Since this trial is completed and I can no longer enroll, are there any follow-on trials or approved therapies based on similar mechanisms that you'd recommend I look into for relapsed or refractory mantle cell lymphoma?
4How does ICP-022 work compared to other BTK inhibitors or treatments already approved for mantle cell lymphoma, and would any of those be a better-supported option for me right now given the more established safety and efficacy data?
5Given that my lymphoma is relapsed or refractory, how would you use the results from this completed trial to help guide decisions about what treatment path makes the most sense for me next?
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.