Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma (NCT03282396) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma
United States20 participantsStarted 2020-06-08
Plain-language summary
This phase II trial studies how well ibrutinib works in treating participants with untreated high risk smoldering mental cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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:
* Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity or cyclin D1 negative MCL classic histology in tissue biopsy. Patients must have never received any prior therapy for their disease. Patients have been observed for 3 - 6 months with no progression as per imaging assessments
* High risk smoldering MCL (i.e. patients without any B symptoms or any symptoms related to MCL warranting immediate systemic therapy) with at least one or more of these eligibility criteria:
* Ki-67 of 15-30% (Ki-67% from involved tissue not bone marrow \[BM\], unless confirmed by pathologist),
* White blood cells (WBC) 15-30k
* Lymph node size 3-5 cm in diameter
* Complex karyotype
* TP53 mutated or wild type and/or del17p (fluorescence in situ hybridization \[FISH\]% 10-50%)
* MYC positive MCL. MYC positive (either by FISH or by immunohistochemistry \[IHC\] and confirmed by pathology at MD Anderson Cancer Center \[MDACC\])
* Presence of either or KMT2D, BIRC3, NOTCH2, NSD2 or more than one mutation in the initial next generation sequencing (NGS) panel testing are allowed
* Understand and voluntarily sign an institutional review board (IRB)-approved informed consent form
* Age \>= 18 years at the time of signing the informed consent
* Patients should in general have bi-dimensional measurable disease with their biggest tumor less than or equal to 5 cm. (Bone marrow or gastrointestinal \[GI\] only involvement is acceptable)
* Eastern Cooperative Oncology Gr…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.