Intergroup Randomized Phase 2 Four Arm Study In Patients = 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB ? R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV? R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB ? LR) or Arm D
This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
Additional Principal Investigators: Andrea Harzstark- San Francisco
Primary
To determine whether the addition of bortezomib (RBV) to an induction regimen of rituximab-bendamustine hydrochloride (RB) improves progression-free survival (PFS) compared to RB alone in patients = 60 years of age with previously untreated mantle cell lymphoma.
To determine whether the addition of lenalidomide to a consolidation regimen of rituximab following an induction regimen of RB or RBV improves PFS compared to consolidation rituximab alone in this patient population.
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Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH;)
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Patients must have at least one objective measurable disease parameter
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* Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
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* Measurable disease in the liver is required if the liver is the only site of lymphoma;
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ECOG performance status 0-2;
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AST/ALT < or = 2 times upper limit of normal (ULN);
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Bilirubin < or = 2 times ULN;
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Calculated creatinine clearance by Cockroft-Gault formula > or = 30 mL/min;
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Patient must have no CNS involvement;
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Please contact study team for additional inclusion criteria;
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Evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically or radiation-cured malignancy continuously disease free for = 5 years so as not to interfere with interpretation of radiographic response;
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Patients who have grade 2 or greater peripheral neuropathy;
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Patients who have NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia;
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Patients who have hypersensitivity to bortezomib, boron, or mannitol;
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Patients who have a serious medical or psychiatric illness likely to interfere with study participation;
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Please contact study team for additional exclusion criteria;
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Antineoplastic Agents, Alkylating
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contiguous stage II mantle cell lymphoma
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Immunoproliferative Disorders
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Lymphoproliferative Disorders
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Molecular Mechanisms of Pharmacological Action
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Neoplasms by Histologic Type
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Nitrogen Mustard Compounds
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noncontiguous stage II mantle cell lymphoma
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Physiological Effects of Drugs
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stage I mantle cell lymphoma
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stage III mantle cell lymphoma
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stage IV mantle cell lymphoma
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Substance-Related Disorders
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