Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00081861|
Recruitment Status : Completed
First Posted : April 27, 2004
Results First Posted : August 26, 2009
Last Update Posted : April 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Avastin Drug: Rituximab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Avastin Plus Rituximab for Patients With Relapsed and Chemotherapy- or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
Experimental: Avastin + Rituximab
Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
10 mg/kg given intravenously every 2 weeks for 4 doses.
Other Name: BevacizumabDrug: Rituximab
375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.
Other Name: Rituxan
- Number of Participants With Response (Complete Response or Progressive Disease) [ Time Frame: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab), ]Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as "complete disappearance" of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081861
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Barbara Pro, MD||M.D. Anderson Cancer Center|