Conditions: Diffuse Large B-Cell Lymphoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 164
Healthy volunteers: no

Brief summary:
This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Detailed description:

Arms:
arm 1: VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles. arm 2: R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone

Interventions: intervention 1: VELCADE intervention 2: Rituximab intervention 3: Cyclophosphamide intervention 4: Doxorubicin intervention 5: Prednisone intervention 6: Vincristine
Intervention descriptions: intervention 1: VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles. intervention 2: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles intervention 3: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles intervention 4: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles intervention 5: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles intervention 6: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Protocol document: