Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma

Running, not enrolling · Phase 2

Conditions studied: Blastoid Variant Mantle Cell Lymphoma, Mantle Cell Lymphoma, Pleomorphic Variant Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID: NCT02427620
Run by: M.D. Anderson Cancer Center
People needed: 131
Starts: 2015-06-03
Expected to finish: 2027-06-30
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form
Pregnant or breast feeding females
Known human immunodeficiency virus (HIV) infection
Patients with active hepatitis B or C infection (not including patients with prior hepatitis B vaccination); these patients should be cleared by gastrointestinal (GI) consultation for hepatitis B and infectious disease consult for hepatitis C
All patients with central nervous system lymphoma
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis unless due to lymphoma
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or any other gastrointestinal condition that could interfere with the absorption and metabolism of ibrutinib
Major surgery within 4 weeks of initiation of therapy; clearance letter from primary physician required
Requires anticoagulation with warfarin or equivalent vitamin K antagonist
Requires treatment with strong cytochrome P4503A (CYP3A) inhibitors
Patients with New York Heart Association (NYHA) class III and IV heart failure, myocardial infarction in the preceding 6 months, and significant conduction abnormalities, including but not limited to 2nd degree atrioventricular block (AV block) type II, 3rd degree block, QT prolongation (corrected QT [QTc] > 500 millisecond [msec]), sick sinus syndrome, ventricular tachycardia, symptomatic bradycardia (heart rate < 50 beats per minute [bpm]), hypotension, light headedness and syncope; patients with persistent and uncontrolled atrial fibrillation will be excluded; the protocol excludes patients who have recently had a stent and by recommendation of their cardiologist need to stay on anticoagulants such as warfarin or equivalent vitamin K antagonist
Acute infection requiring treatment (IV antibiotics, antivirals, or antifungals) within 14 days prior to initiation of study

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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