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

Inclusion Criteria

• Patients must have a pathologically confirmed diagnosis of DLBCL (including DLBCL not otherwise specified [NOS], DLBCL germinal center B-cell [GCB] type, DLBCL activated B cell [ABC]/non-GCB type, T cell/histiocyte-rich large B cell lymphoma, high-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B cell lymphoma NOS). NOTE: DLBCL transformed from low-grade lymphoma among treatment-naive patients or patients previously treated with a non-anthracycline containing regimen are permitted
• Patients may have completed the first cycle of R-CHOP (off study not combined with TAK-659) = = 4, at time of diagnosis
• MYC gene rearrangement (by [fluorescent in situ hybridization] FISH)
• MYC overexpression by immunohistochemistry (IHC) (>= 40%) and BLC2 overexpression by IHC (>= 50%) or
• Previously treated transformed low-grade lymphoma to large B cell lymphoma with prior treatment not including an anthracycline
• NOTE: BCL2 and/or BCL6 aberrancy are not required for enrollment, but assessment for rearrangement by FISH and overexpression by IHC are required if there is presence of MYC rearranged by FISH
• Patients must have measurable disease (defined as >= 1.5 cm in diameter) with correlated fluorodeoxyglucose (FDG)-avidity on positron emission tomography (PET) scan with Deauville score of 4 or 5 at time of diagnosis
• Patients must have recovered (i.e., = = 1000/mcL (within 14 days prior to registration)
• Platelets >= 75, 000/mcl (NOTE: Patients with bone marrow involvement may be eligible with platelets >= 50,000) (within 14 days prior to registration)
• Hemoglobin >= 8 g/dL (within 14 days prior to registration)
• NOTE: Red blood cell (RBC) and platelet transfusion allowed >= 14 days prior to registration
• Total bilirubin = = 60 mL/min either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours) (within 14 days prior to registration)
• Lipase = 4 weeks) are not eligible
• NOTE: Patients may receive R-CHOP cycle 1
• NOTE: If patient is registered prior to completion of washout, start date of treatment will need to be confirmed prior to registration
• Use or consumption of the following substances is not permitted:
• Medications or supplements that are known to be inhibitors of P-gp and/or strong reversible inhibitors of CYP3A within 5 times the inhibitor half-life (if a reasonable half-life estimate is known), or within 7 days (if a reasonable half-life estimate is unknown), before the first dose of study drug. The use of these agents is not permitted during the study
• Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days, or within 5 times the inhibitor or inducer half-life (whichever is longer), before the first dose of study drug. The use of these agents is not permitted during the study
• Grapefruit-containing food or beverages within 5 days before the first dose of study drug. Note that grapefruit-containing food and beverages are prohibited during the study
• Patients who have major surgery, per principal investigator (PI) discretion, = grade 1 despite supportive therapy)
• Patients who received treatment with high-dose corticosteroids for anticancer purposes = 450 milliseconds (msec) (men) or > 475 msec (women) on a 12-lead electrocardiography (ECG) during the screening period
• Abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that, in the opinion of the investigator, are considered to be clinically significant
• Abnormal left ventricular function (ejection fraction [EF] < 50%, as indicated by baseline echocardiography [ECHO])
• Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of TAK-659