Conditions: Non-Hodgkin's Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 46
Healthy volunteers: no

Brief summary:
The purpose of this trial is to investigate the efficacy (how well the drug works) of ofatumumab and lenalidomide in patients with lymphoma and to investigate if any possible unwanted side effects may occur. The purpose of the Phase I portion of this trial will be to determine the maximum dose of these medications that can be given with minimal side effects.

Detailed description:
This trial will investigate the efficacy of ofatumumab and lenalidomide in patients with lymphoma and investigate if any possible unwanted side effects may occur. Ofatumumab is a human antibody (a type of protein) that binds specifically to a protein (CD20) on the surface of some of the white blood cells (B-cells). Research, so far, has shown that ofatumumab can destroy cancer cells which originate from B cells. Ofatumumab is approved for sale by the US Food and Drug Administration (FDA). The medicine has an approved indication for Chronic Lymphocytic Leukemia (CLL) but is not approved for Non-Hodgkin's Lymphoma (NHL).

Lenalidomide is a drug that affects the immune system. Lenalidomide can change the body's immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the FDA for treatment of multiple myeloma (MM) and myelodysplastic syndrome (MDS) and has been shown to be effective in lymphoma that does not respond to treatment or has come back after treatment. Lenalidomide has not been approved by the United States (US) Food and Drug Administration (FDA) and is experimental (investigational) in this study.

Arms:
arm 1: All participants will receive the same dose of Ofatumumab. There will be three planned dose cohorts for the Lenalidomide in the Phase 1 portion of this trial. A maximum of 18 patients will be enrolled in to Phase 1. Three evaluable patients will be enrolled in to each of the dose cohorts with an additional 3 patients to be enrolled in the maximum tolerated dose (MTD). An additional 29 evaluable patients will be enrolled in to Phase II using the MTD for Lenalidomide that was determined in Phase 1.

Interventions: intervention 1: Lenalidomide intervention 2: ofatumumab
Intervention descriptions: intervention 1: Dose Cohort -1\^ 10mg daily on Days 1-21 every 28 days

Dose Cohort +1\^\^ 15mg daily on Days 1-21, every 28 days

Dose Cohort +2 20 mg daily on Days 1-21, every 28 days

Dose Cohort #3 25 mg daily on Days 1-21, every 28 days

\^Used only if Dose Cohort +1 requires further reduction

\^\^Starting Dose Cohort in Phase I intervention 2: 8 weekly infusions of ofatumumab 1000mg.

Protocol document: