NCT01060384

Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase I/II Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	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
DRUG	ofatumumab	8 weekly infusions of ofatumumab 1000mg.

Timeline

• Start date: 2010-03-29
• Primary completion: 2016-10-25
• Completion: 2018-01-01
• First posted: 2010-02-02
• Last updated: 2023-10-04
• Results posted: 2018-08-08

Locations

2 sites across 1 country: United States