A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkin's Lymphoma
This is a multicenter, prospective study.
- Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15,
and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on
day 1 of all subsequent courses. Treatment repeats every 35 days for 3 courses.
Patients achieving a complete response, partial response, or stable disease proceed to
- Maintenance therapy: Beginning 6-8 weeks after induction therapy, patients receive
bortezomib IV over 3-5 seconds and rituximab IV on day 1. Treatment repeats every 60
days for up to 4 courses in the absence of disease progression or unacceptable
Blood and tissue samples are collected at baseline and periodically during study treatment.
After completion of study therapy, patients are followed every 3 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete response and partial response)
The primary objective of this study is to assess the overall response rate (complete response [CR] plus partial response [PR]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.
baseline, every 2 months at the completion of cycles 1, 2 and 3 and 2 months after cycle 3 completion and then every 6 mo for 2 yrs
Andrew M. Evens, DO, MS
United States: Food and Drug Administration
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Hematology-Oncology Associates of Illinois||Chicago, Illinois 60611-2998|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Northwestern University||Chicago, Illinois 60611|