Lymphoma Clinical Trial
Official title:
A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #12373) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, can block cancer growth
in different ways. Some block the ability of cancer cells to grow and spread. Others find
cancer cells and help kill them or carry cancer-killing substances to them. Giving more than
one monoclonal antibody may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab
works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
- Determine the overall and complete response rate in patients with previously untreated
CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
treated with rituximab and galiximab.
- Determine the time to disease progression in patients treated with this regimen.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Correlate Fc receptor polymorphism profiling with response in patients treated with
this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and
galiximab IV over 1 hour on day 3, 8, 15, and 22.
- Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients
receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for
4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 4 months for up to 10
years.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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