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

Part of paid clinical trials in La Jolla, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT00486759
Phase
PHASE3
Status
Terminated

Conditions

  • B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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 — DRUG
    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.
  • CHOP — DRUG
    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 — DRUG
    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.

Study Details

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).

Key Dates

Start date
Jul 26, 2007
Status verified
Jun 2017
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
787 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + rituximab + CHOP
    Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m\^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone).
  • Active Comparator: Placebo + rituximab + CHOP
    Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m\^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone).

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Baseline to end of the study (up to 4 years, 4 months) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Uni of California - San Diego; Cancer Center & Dept of MedicineLa JollaCalifornia92093-
Kenmar Research Inst.WhittierCalifornia90603-
University of Colorado Cancer Center Department of HematologyAuroraColorado80045-
Uni Medical Center; Division Of Hemotology/OncologyJacksonvilleFlorida32207-
Florida Cancer SpecialistsWest Palm BeachFlorida33401-
Northwest Georgia Oncology CentersMariettaGeorgia30060-
University of Kansas Medical Center; Department of HematologyKansas CityKansas66160-
St. Joseph Mercy Hospital; Department of OncologyAnn ArborMichigan48106-
Northeast Oncology AssociatesConcordNorth Carolina28025-
Forsyth Regional Cancer Center; Piedmont Hematology/Oncology AssociatesWinston-SalemNorth Carolina27103-
Providence Portland Medical CenterPortlandOregon97213-
Charleston Cancer CenterCharlestonSouth Carolina29406-
Uni of Texas Southwestern Medical CenterDallasTexas75390-9063-
Cancer Therapy & Research CenterSan AntonioTexas78229-
Northwest Medical Specialties BFederal WayWashington98003-
Rainier PhysiciansPuyallupWashington98372-
Northwest Medical SpecialtiesTacomaWashington98405-

Find similar trials in La Jolla, CA

By research site
Uni of California - San Diego; Cancer Center & Dept of Medicine· La Jolla, CAKenmar Research Inst.· Whittier, CAUniversity of Colorado Cancer Center Department of Hematology· Aurora, COUni Medical Center; Division Of Hemotology/Oncology· Jacksonville, FLFlorida Cancer Specialists· West Palm Beach, FLNorthwest Georgia Oncology Centers· Marietta, GA

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