Ibrutinib Plus Rituximab and Lenalidomide in Treating Elderly Participants With Newly Diagnosed M… (NCT03232307) | Clinical Trial Compass
WithdrawnPhase 2
Ibrutinib Plus Rituximab and Lenalidomide in Treating Elderly Participants With Newly Diagnosed Mantle Cell Lymphoma
Stopped: Sponsor does not wish to proceed
0Started 2019-07-01
Plain-language summary
This phase II trial studies how well ibrutinib plus rituximab and lenalidomide work in treating elderly participants with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib plus rituximab and lenalidomide may work better in treating elderly participants with newly diagnosed mantle cell lymphoma.
Who can participate
Age range
66 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 in tissue biopsy.
* Ki-67 \>= 50%.
* Patients must have never received any prior systemic therapy for their disease.
* Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Patients should in general have bi-dimensional measurable disease using the Cheson criteria (measurable disease by computed tomography \[CT\] scan defined as at least 1 lesion that measures \>= 1.5 cm in single dimension) (bone marrow or gastrointestinal \[GI\] only involvement is acceptable).
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
* Absolute neutrophil count (ANC) \>= 1000/mm\^3 without transfusion support.
* Platelet count \> 100,000/mm\^3. Patients who have bone marrow infiltration by MCL are eligible if their platelet level is \>= 50,000 /mm\^3 independent of platelet transfusions.
* Aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) =\< 3 x upper limit of normal.
* Serum bilirubin \< 1.5 mg/dl unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
* Creatinine (Cr) clearance \>= 25 mL/min (per Cockcroft-Gault equation).
* Disease free of prior malignancies of equal to or greater than 6 months with exception…
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.
What they're measuring
1
Overall response rate (ORR) per International Workshop Standardization Response Criteria for non-Hodgkin's lymphoma