Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma
1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).
- To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.
- To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)|
- effect of bevacizumab + CHOP-rituximab on untreated mantle cell lymphoma [ Time Frame: duration of study ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401817
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||John P Leonard, MD||Weill Medical College of Cornell University|