NCT01239394

Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Phase II Trial Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of cancerous B cells, and then triggering the death of those cells. It is approved by the FDA for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence of success in people who's B-cell lymphomas have relapsed after initial treatments. In this research study we are looking to see if ofatumumab is effective and safe in treating previously untreated B-cell NHL.

Detailed description

* Participants will receive ofatumumab once a week for 8 weeks by intravenous infusion (Days 1, 8, 15, 22, 29, 36, 43, and 50). * Participants will be seen weekly during the 8 week treatment period and will have the following tests and procedures performed: Blood tests, performance status and physical examination.

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	ofatumumab	Weekly infusion for 8 weeks

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-03-01
• Completion: 2015-03-01
• First posted: 2010-11-11
• Last updated: 2017-10-18
• Results posted: 2017-03-17

Locations

3 sites across 1 country: United States