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
Stopped early · Phase 3 · Has a placebo group
Conditions studied: B-cell Lymphoma
In brief
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 facts
- Study ID
- NCT00486759
- Run by
- Hoffmann-La Roche
- People needed
- 787
- Starts
- 2007-07-26
- Expected to finish
- 2011-11-30
- Last updated by the study team
- 2017-07-25
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Kenmar Research Inst. — Whittier, California, United States
- University of Colorado Cancer Center Department of Hematology — Aurora, Colorado, United States
- Uni Medical Center; Division Of Hemotology/Oncology — Jacksonville, Florida, United States
- Florida Cancer Specialists — West Palm Beach, Florida, United States
- Northwest Georgia Oncology Centers — Marietta, Georgia, United States
- University of Kansas Medical Center; Department of Hematology — Kansas City, Kansas, United States
- St. Joseph Mercy Hospital; Department of Oncology — Ann Arbor, Michigan, United States
- Northeast Oncology Associates — Concord, North Carolina, United States
- Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates — Winston-Salem, North Carolina, United States
- Providence Portland Medical Center — Portland, Oregon, United States
- Charleston Cancer Center — Charleston, South Carolina, United States
- Uni of Texas Southwestern Medical Center — Dallas, Texas, United States
- Cancer Therapy & Research Center — San Antonio, Texas, United States
- Northwest Medical Specialties B — Federal Way, Washington, United States
- Rainier Physicians — Puyallup, Washington, United States
- Northwest Medical Specialties — Tacoma, Washington, United States
- Hospital Italiano; Haemathology — Buenos Aires, Argentina
- Fundaleu; Haematology — Buenos Aires, Argentina
- Hospital Britanico; Haematology — Buenos Aires, Argentina
- HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología — Córdoba, Argentina
- Greenslopes Private Hospital; Gallipoli Research Centre — Greenslopes, Queensland, Australia
- Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology — Woolloongabba, Queensland, Australia
- Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science — Adelaide, South Australia, Australia
- Ashford Cancer Center Research — Kurralta Park, South Australia, Australia
- Uni of California - San Diego; Cancer Center & Dept of Medicine — La Jolla, California, United States
Full record on ClinicalTrials.gov
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