A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: enzastaurin; rituximab; cyclophosphamide; doxorubicin; vincristine; prednisone
Intervention description: 1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years; 375 milligrams per square meter (mg/m^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles; 750 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles; 50 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles; 1.4 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles; 100 mg, oral, Days 1-5, six 21-day cycles
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time
      measured in participants with intermediate and/or high risk for diffuse large B-cell lymphoma
      (DLBCL) receiving first-line treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants must:

          1. 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.

          2. Have received no prior chemotherapy.

          3. Have an International Prognostic Index (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 (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.

             Exclusion Criteria:

             Participants must not:

          6. 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.

          7. Are receiving concurrent administration of any other systemic anticancer therapy.

          8. Are pregnant or breastfeeding.

          9. Are unable to swallow tablets.

         10. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least
             14 days prior to study enrollment.