Lymphoma, Low-Grade, Lymphoma, Non-Hodgkin
Conditions
Keywords
Radioimmunotherapy, Antigens, CD20
Brief summary
The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.
Detailed description
The objective of this study is to determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (\> 5 cm in greatest diameter) disease. To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites were activated. The study has subsequently closed to accrual. Currently 8 sites remain active to follow the 12 subjects enrolled in the past year.
Interventions
DRUGibritumomab tiuxetan (Zevalin®)
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Follicular non-Hodgkin's lymphoma including SLL in first or second relapse. * No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory. * Age \>= 18 years, not pregnant or lactating. * Expected survival \>= 3 mths; PS 0, 1, or 2. * ANC \>= 1,500/mm3, platelet counts \>= 100,000/mm3. * Total bilirubin \> 2.0 mg/dL, creatinine \> 2.0 mg/dL. * Total lymphocyte count \< 5,000/mm3 for SLL. * \<25% bone marrow involvement with lymphoma.
Exclusion criteria
* Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection. * Bulky areas of disease more than 10 cm in diameter. * Patients with CLL, CNS, or mantle cell lymphoma. * Hx of HIV/AIDS related lymphoma, hepatitis B or C. * Prior radioimmunotherapy or XRT to \>25% of active bone marrow. * G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease. | — |
Countries
United States
Outcome results
None listed