Conditions: Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.

Interventions: intervention 1: Ofatumumab intervention 2: Bortezomib
Intervention descriptions: intervention 1: Given intravenously intervention 2: Given intravenously

Protocol document: