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 range18 Years – 65 Years
SexALL
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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 …