Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I Study of BKM120 and Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma
This phase I clinical trial studies the side effects and the best dose of phosphatidylinositol-3-kinase (PI3K) inhibitor BKM120 when given together with rituximab in treating patients with relapsed or refractory low-grade B-cell lymphoma. PI3K inhibitor BKM120 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving PI3K inhibitor BKM120 with rituximab may be an effective treatment for B-cell lymphoma.
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of combined rituximab and BKM120 (PI3k inhibitor BKM120) in patients with previously treated indolent non-Hodgkin lymphoma (NHL) (including follicular lymphoma (FL), marginal zone lymphoma, and lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia), and mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. To determine specific toxicities associated with combined BKM120 and rituximab. II. Evaluate for efficacy of BKM120 in combination with rituximab in these diseases. OUTLINE: This is a dose-escalation study of PI3K inhibitor BKM120. Patients receive PI3K inhibitor BKM120 orally (PO) daily on days 1-28 and rituximab intravenously (IV) on days 2, 8, 15, and 22 of course 1 and on day 1 of courses 3, 5, 7, 9, and 11. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with asymptomatic progression may continue treatment for up to 12 months. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years. ;
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|---|---|---|---|
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