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Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
Primary Objective 1\. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL). Secondary Objectives 1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL. 2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.
Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications) Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment Once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Rush University Medical Center
Chicago, Illinois, United States
Weill Medical College of Cornell University
New York, New York, United States
Start Date
November 1, 2007
Primary Completion Date
July 1, 2011
Completion Date
November 1, 2013
Last Updated
October 20, 2017
11
ACTUAL participants
Bevacizumab
DRUG
Rituximab
DRUG
CHOP
DRUG
Lead Sponsor
Weill Medical College of Cornell University
Data Source & Attribution
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