A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
Condition: B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Bevacizumab; Rituximab; CHOP; Placebo
Intervention description: Bevacizumab was administered at a dose of 15 mg/kg IV on Day 1 of each 21-day cycle for 8 cycles or at a dose 10 mg/kg IV on Day 1 of each 14-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.; Rituximab was administered at a dose of 375 mg/m^2 IV on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.; Cyclophosphamide was administered at a dose of 750 mg/m^2 IV on Day 1 of each cycle. Doxorubicin was administered at a dose of 50 mg/m^2 IV on Day 1 of each cycle. Vincristine was administered at a dose of 1.4 mg/m^2 IV (maximum of 2 mg) on Day 1 of each cycle. Prednisone was administered at a dose of 100 mg orally on Days 1-5 of each cycle. All 4 drugs were administered either every 21 days for 8 cycles or every 14 days for 6 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.; Placebo to bevacizumab was administered on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
Intervention MeSH terms: Bevacizumab; Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 787.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in
      combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin
      [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus
      CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large
      B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with
      R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP
      was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average
      dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 and < 80 years of age.

          -  CD20-positive diffuse large B-cell lymphoma.

          -  Low-intermediate, high-intermediate, or high risk disease and/or bulky tumor (largest
             diameter ≥ 7.5 cm).

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

        Exclusion Criteria:

          -  Prior treatment for diffuse large B-cell lymphoma.

          -  Types of non-Hodgkin's lymphoma other than diffuse large B-cell lymphoma (DLBCL).

          -  Central nervous system (CNS) involvement of lymphoma.