Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma
18 Years
N/A
Both
Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade
Trial Information
Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
Wayne Saville
Investigator Role:
Study Director
Investigator Affiliation:
Biogen Idec
Authority:
United States: Food and Drug Administration
Study ID:
001-03-ZEV
NCT ID:
NCT00168727
Start Date:
June 2003
Completion Date:
October 2005
Related Keywords:
- Lymphoma, Non-Hodgkin
- Lymphoma, Low-Grade
- Radioimmunotherapy
- Antigens, CD20
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Loma Linda University | Loma Linda, California 92354 |
| Presbyterian Hospital Cancer Center | Charlotte, North Carolina 28204 |
| North County Oncology | Oceanside, California 92056 |
| Medical Specialists of Fairfield | Fairfield, Connecticut |
| Queens Hospital | Honolulu, Hawaii |
| Northwest Oncology and Hematology | Elk Grove Village, Illinois |
| Horizon Oncolgy Center | Lafayette, Indiana |
| Specialists in Hematology/Oncology | St. Louis, Missouri |
