Conditions

Outcome Measures

Progression-Free Survival (PFS) Time
PFS time is the elapsed time from the date of randomization to the first date of objectively-determined PD or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (other than enzastaurin maintenance therapy) prior to objectively determined disease progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of subsequent therapy.
Randomization to measured PD or death from any cause (up to 55 months)

Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate)
Baseline through long-term follow-up (up to 2 years post last dose)
Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate)
Randomization to measured PD (up to Year 2)
Percentage of Participants With a PET-Negative Scan (PET-Negative Rate)
Cycle 6 (21 days/cycle)
Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan)
Cycle 6 (21 days/cycle)
Event-Free Survival (EFS)
Randomization to measured PD, start of new therapy, or death from any cause (up to 55 months)
+4 more secondary outcomes

EXPERIMENTAL

R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.

Drug: enzastaurinDrug: rituximabDrug: cyclophosphamideDrug: doxorubicinDrug: vincristineDrug: prednisone

ACTIVE COMPARATOR

R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.

Drug: rituximabDrug: cyclophosphamideDrug: doxorubicinDrug: vincristineDrug: prednisone

1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years

Also known as: LY317615

R-CHOP and Enzastaurin

375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles

R-CHOPR-CHOP and Enzastaurin

750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles

R-CHOPR-CHOP and Enzastaurin

50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles

R-CHOPR-CHOP and Enzastaurin

1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles

R-CHOPR-CHOP and Enzastaurin

100 mg, oral, Days 1-5, six 21-day cycles

R-CHOPR-CHOP and Enzastaurin

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Participants must:
Have a histologically confirmed diagnosis of DLBCL based on the World Health Organization classification (Harris et al. 1999) at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the participant is entered. Participants with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be eligible for enrollment.
Have received no prior chemotherapy.
Have an International Prognostic Index (IPI) score ≥2 at time of original diagnosis.
Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale.
Have adequate organ function as follows:
Hepatic: total bilirubin ≤1.5 times the upper limit of normal (x ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤1.5 x ULN, (≤5 x ULN, if liver involvement).
Renal: serum creatinine ≤1.5 x ULN.
Adequate bone marrow reserve: platelets ≥75 x 10\^9 per Liter (L), absolute neutrophil count (ANC) ≥1.0 x 10\^9 per L, unless there is bone marrow involvement.

Participants must not:
Have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry.
Are receiving concurrent administration of any other systemic anticancer therapy.
Are pregnant or breastfeeding.
Are unable to swallow tablets.
Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.

Contact the study team to confirm eligibility.