Lymphoma Clinical Trial
Official title:
A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma
RATIONALE: Monoclonal antibodies, such as 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.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with
relapsed or refractory Hodgkin's lymphoma.
OBJECTIVES:
Primary
- To determine the response rate (complete and overall response) in patients with
relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.
Secondary
- To assess the duration of response, progression-free survival, and overall survival of
patients with relapsed or refractory HL.
- To assess the safety and tolerability of galiximab in patients with relapsed or
refractory HL.
- To determine if FDG-PET correlates with outcome in patients with relapsed or refractory
HL treated with galiximab.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive galiximab IV over 60 minutes on days 1, 8, 15, and
22 in month 1.
- Extended induction therapy: Patients receive galiximab IV over 60 minutes once every
four weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within
7 days prior to week 8 treatment).
After completion of study treatment, patients are followed periodically for 10 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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