| Inclusion Criteria: | 1) Have a histologically confirmed diagnosis of DLBCL based on the World Health Organization classification at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the patient is entered. Patients with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be eligible for enrollment.
2) Have received no prior chemotherapy.
3) Have an IPI score = 2 at time of original diagnosis.
4) Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale.
5) Have adequate organ function as follows: Hepatic: total bilirubin </=1.5 times the upper limit of normal (× ULN); alanine transaminase (ALT) and aspartate transaminase (AST) </= 1.5 × ULN, (</=5 × ULN, if liver involvement); Renal: serum creatinine </= 1.5 × ULN;Adequate bone marrow reserve: platelets >/= 75 × 10^9/L, absolute neutrophil count (ANC) >/= 1.0 × 10^9/L, unless there is bone marrow involvement.
6) Have a normal left ventricular ejection fraction of >/= 50% by echocardiography or nuclear medicine multi-gated (MUGA) scan.
7) Are at least 18 years of age.
8) Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test </= 3 days prior to study enrollment.
9) Must agree to participate in PGx sampling and analysis.
10) Have an estimated life expectancy of at least 12 weeks.
11) Must sign an informed consent document (or legal representative has given informed consent).
12) Exhibit patient compliance and geographic proximity that allow for adequate follow-up. |