A Study of Avastin (Bevacizumab) in Combination With MabThera (Rituximab) and CHOP Chemotherapy in Patients With Diffuse Large B-Cell Lymphoma


Tracking Information

Start Date  ICMJEJuly 2007
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 HistoryComplete list of historical versions of study NCT00486759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 18, 2008)
  • Overall survival, event-free survival, disease-free survival, overall response rate, complete response rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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  ICMJEA Study of Avastin (Bevacizumab) in Combination With MabThera (Rituximab) and CHOP Chemotherapy in Patients With Diffuse Large B-Cell Lymphoma.
Official Title  ICMJEA 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJELymphoma, B-Cell
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    5mg/kg / week dosing equivalent iv
  • Drug: R-CHOP
    As prescribed
  • Drug: Placebo
    iv/week
Study Arms / Comparison Groups
  • 1: Experimental
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: R-CHOP
  • 2: Placebo Comparator
    Interventions:
    • Drug: R-CHOP
    • Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1000
Estimated Completion DateMarch 2016
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • CD20-positive diffuse large B-cell lymphoma;
  • low-intermediate, high-intermediate or high risk disease and/or bulky tumor (.7.5 cm);
  • ECOG performance status 0-2.

Exclusion Criteria:

  • prior treatment for diffuse large B-cell lymphoma;
  • types of non-Hodgkin's lymphoma other than DLBCL;
  • CNS involvement of lymphoma.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BO20603888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEUnited 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  ICMJENCT00486759
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBO20603
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJEGenentech
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche