Tracking Information
Start Date ICMJE | July 2007 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: January 18, 2008) | Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: June 14, 2007) | Progression-free survival |
Change History | Complete list of historical versions of study NCT00486759 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: January 18, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: June 14, 2007) | Efficacy: Overall survival, event-free survival, disease-free survival, overall response rate, complete response rate. Safety: AEs, laboratory parameters. |
Descriptive Information
Brief Title ICMJE | A Study of Avastin (Bevacizumab) in Combination With MabThera (Rituximab) and CHOP Chemotherapy in Patients With Diffuse Large B-Cell Lymphoma. |
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Official Title ICMJE | A Randomized, Double-blind Placebo-controlled Study Comparing the Effect of Avastin in Combination With MabThera Plus CHOP, and MabThera Plus CHOP Alone, on Progression-free Survival in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma. |
Brief Summary | This 2 arm study will compare the efficacy and safety of Avastin in combination with MabThera and CHOP chemotherapy (RA-CHOP) versus MabThera plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients will be randomized to 8 cycles of treatment with R-CHOP plus Avastin, or R-CHOP plus placebo. The treatment with Avastin/Placebo and R-CHOP will be given either as a 2 weekly or 3 weekly schedule, and Avastin will be given at a weekly average dose of 5mg/kg (10mg/kg for 2 weekly cycles and 15mg/kg for 3 weekly cycles). Responding patients will continue on Avastin monotherapy (15mg/kg every 3 weeks) for up to 1 year. The anticipated time on treatment is 3-12 months, and the target sample size is 500+ individuals. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Lymphoma, B-Cell |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1000 | ||||
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Estimated Completion Date | March 2016 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Brazil, Canada, China, Colombia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay |
Administrative Information
NCT ID ICMJE | NCT00486759 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | BO20603 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | Genentech | ||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |