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Brief Title: Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma
Official Title: Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
Study ID: NCT00401817
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
Name: John P Leonard, MD
Affiliation: Weill Medical College of Cornell University
Role: PRINCIPAL_INVESTIGATOR