Non-Hodgkin's Lymphoma
Conditions
Brief summary
The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease.
Interventions
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Summary of major inclusion and
Exclusion criteria
. Other Safety criteria will need to be met. Inclusion Criteria: * Histologically confirmed, relapsed or refractory CD20+ follicular B-cell NHL within 12 months of Study Day 1 (without clinical evidence of transformation). NHL must require treatment as determined by an increase in overall tumor size. The presence of B symptoms, and/or the presence of masses which are causing ongoing clinical symptoms. * Bidimensionally measurable disease meeting the minimum requirement of at least 1 lesion \>/= 2.0 cm in a single dimension. * No lymphoma therapy for 3 weeks prior to Study Day 1. * Patients must be recovered from all toxicities associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy. * Signed IRB-approved informed consent. * Greater than 18 years of age. * Expected survival \>/= 3 months. * WHO performance status of \</= 2. * Acceptable hematologic status, liver function, renal function, and pulmonary function. * Female patients who are not pregnant or lactating. * Men and women of reproductive potential who are following accepted birth control methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate | — |
| unconfirmed complete response rate | — |
| partial response rate | — |
| duration of response | — |
| overall response rate | — |
| time-to-next anticancer therapy | — |
| quality of life | — |
| overall survival | — |
| safety profile | — |
| time to progression | — |
Countries
United States
Outcome results
None listed