Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma

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PRIMARY OBJECTIVES: I. To determine the safety, tolerability, and maximum tolerated dose of TAK-659 when combined with R-CHOP in the front-line treatment of high-risk diffuse large B cell lymphoma (DLBCL). SECONDARY OBJECTIVES: I. To assess preliminary efficacy of TAK-659 combined with R-CHOP in the...

PRIMARY OBJECTIVES: I. To determine the safety, tolerability, and maximum tolerated dose of TAK-659 when combined with R-CHOP in the front-line treatment of high-risk diffuse large B cell lymphoma (DLBCL). SECONDARY OBJECTIVES: I. To assess preliminary efficacy of TAK-659 combined with R-CHOP in the front-line treatment of high-risk DLBCL. EXPLORATORY OBJECTIVES: I. To characterize the pharmacokinetics (PK) of TAK-659 in combination with R-CHOP. OUTLINE: This is a dose-escalation study of spleen tyrosine kinase inhibitor TAK-659. Patients receive rituximab intravenously (IV), cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in course 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 PO once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.

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