Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Phase II Trial of Ofatumumab and Bortezomib in Subjects With Relapsed Cluster of Differentiation Antigen 20 (CD20)+ Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma
This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ofatumumab together with bortezomib may help kill more cancer cells
PRIMARY OBJECTIVES:
I. To determine the efficacy, as measured by overall response (complete response (CR) +
partial response (PR)) of ofatumumab in combination with bortezomib in subjects with
relapsed cluster of differentiation (CD)20+ DLBCL, FL or MCL.
SECONDARY OBJECTIVES:
I. To explore duration of efficacy of ofatumumab in combination with bortezomib in the same
population as measured by progression free survival (PFS), overall survival (OS) and disease
free survival (DFS).
II. To assess response as compared to prior treatment. III. To assess the safety and
tolerability of ofatumumab in combination with bortezomib in the same patient population.
TERTIARY OBJECTIVES:
I. Correlation of trough ofatumumab blood levels to response. II. Correlation fragment
crystallizable receptor (FcR) gamma 3 allotype and response.
OUTLINE:
Patients receive ofatumumab intravenously (IV) over 2.5 hours on days 1 and 8 of course 1,
and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on
days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment patients are followed up every 3 months for 2 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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