A Phase II Study of VELCADE With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
OBJECTIVES:
Primary
- Determine the response rate (complete response [CR], CR-unconfirmed [CRu], and partial
response [PR]) in patients with relapsed or refractory indolent B-cell non-Hodgkin's
lymphoma treated with bortezomib and rituximab.
Secondary
- Determine the response rate (CR, CRu, and PR) at the first disease response evaluation
in patients treated with this regimen.
- Determine the overall CR rate (CR and CRu) in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the time to best response in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center, Karnofsky performance status (< 70% vs ≥ 70%), lactic
dehydrogenase level (normal vs > upper limit of normal), age (18 to 60 years vs > 60 years),
and lymphoma subtype (follicular vs marginal zone). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1
of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the
absence of disease progression or unacceptable toxicity.
- Arm II: 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 only. Treatment
repeats every 35 days for up to 3 courses in the absence of disease progression or
unacceptable toxicity.
Patients in either arm may crossover to the other arm if treatment is found to be
ineffective.
Patients are followed at 30 days and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 24-66 patients (12-33 per treatment arm) will be accrued for
this study within 1 year.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response [CR], CR-unconfirmed [CRu], and partial response [PR])
12 weeks
No
Sven De Vos, MD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000390235
NCT00093769
August 2004
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |