| Inclusion Criteria: | 1) Have had a histologically confirmed diagnosis of DLBCL by 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 may be entered and randomized based on local pathology; however, an independent centralized pathology review will be performed on all enrolled patients. Commonly accepted histological variants of DLBCL, such as immunoblastic lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich lymphoma are allowed.
2) If any gallium scan was performed, the most recent gallium scan must be negative. However, gallium scans are not a required study procedure.
3) If any PET scan was performed, the most recent PET scan must be negative, as judged by local radiologist and/or physician (an independent centralized radiology review will also be performed on these patients). Exceptions may be made (after consultaion with the Lilly clinical research physician) for patients with PET-positive lesions in which subsequent confirmation procedure (for instance, biopsy) reveals the lesion is not due to DLBCL. However, PET scans are not a required study procedure.
4) Have completed six to eight 21-day cycles of R-CHOP, or six to eight 14-day cycles of R-CHOP as first-line therapy for DLBCL. The patient must have achieved a CR or CRu (and have not subsequently progressed) according to International Workshop Criteria, or must be PET scan negative, as judged by local radiologist and/or physician (an independent centralized radiology review will also be performed on these patients). instance, biopsy) reveals the lesion is not due to DLBCL. Continued in the next inclusion.
5) Exceptions may be made (after consultation with the Lilly clinical research physician) for patients with PET-positive lesions in which a subsequent confirmation procedure (for instance, biopsy) reveals the subsequent confirmation procedure (for instance, biopsy) reveals the lesion is not due to DLBCL.
6) Have an IPI score >/= 3 at time of original diagnosis.
7) Have had Stage 3 or 4 disease, or have had Stage 2 with bulky disease (defined as >10 cm), at time of original diagnosis.
8) Have given informed consent.
9) Have an estimated life expectancy of at least 12 weeks.
10) Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
11) Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
12) Have adequate organ function as follows: a) Hepatic: total bilirubin </= 1.5 times upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) </= 2.5 times ULN; Renal: serum creatinine <1.5 times ULN; Adequate bone marrow reserve: platelets >/= 50 x 10^9/L, absolute neutrophil count (ANC) >/= 1.0 x 10^9/L, hemoglobin >/= 8 g/dL.
13) 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 within 7 days prior to study enrollment.
14) Are at least 18 years of age.
15) Patients must receive on-study therapy no later than 90 days either from their last cycle (Day 1) of induction therapy or from the last day of consolidation radiotherapy. |