Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagno… (NCT02427620) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma
United States131 participantsStarted 2015-06-03
Plain-language summary
This phase II trial studies how well ibrutinib, rituximab, and consolidation chemotherapy consisting of cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, and cytarabine work in treating young patients 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 cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, and cytarabine, 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 more than one drug (combination chemotherapy) may kill more cancer cells. Giving ibrutinib together with rituximab and consolidation chemotherapy may be a better treatment for mantle cell lymphoma.
Who can participate
Age range
18 Years – 65 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:
* Patient has a confirmed diagnosis of mantle cell lymphoma with CD20 positivity in tissue biopsy
* Patients with MCL must be symptomatic and need immediate therapy; symptoms and nature of MCL include any of the following:
* Blastoid variant
* Pleomorphic variant
* B symptoms
* Mantle Cell International Prognostic Score (MIPI) \> 3
* Ki-67 \>= 30%
* Bulky tumors \> 7 cm or in case of \>= 2 tumors, each \>= 5 cm in diameter
* Disease threatening organ function
* Elevated lactate dehydrogenase (LDH)
* Peripheral blood white blood cell (PB WBC) \> 50,000
* Pancytopenia due to bone marrow MCL
* Patient's choice due to anxiety
* Pain due to lymphoma
* Somatic mutations in the TP53, c-MYC or NOTCH genes
* Size of spleen \>= 20 cm
* Patients with mantle cell lymphoma with any of the following will be considered "high-risk" for the purpose of this protocol:
* Blastoid or pleomorphic histology
* Ki-67 index larger than 30%
* Bulky tumor of larger than 7 cm or in case of multiple tumors, larger than or equal to 5 cm each in diameter
* Somatic mutations in the TP53, c-MYC or NOTCH genes
* Size of spleen \>= 20 cm
* Patient has newly diagnosed disease with no prior therapy
* Understand and voluntarily sign an Institutional Review Board (IRB)-approved informed consent form
* Age =\< 65 years at the time of signing the informed consent
* Patients should have bi-dimensional measurable disease using the Cheson criteria (measurable …
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.