Clinical Trial: Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Ofatumumab in Combination With Glucocorticoids for Primary Therapy of Chronic Graft Versus Host Disease
Brief Summary: To study the safety and side effects of Ofatumumab in the treatment of chronic graft-versus-host disease (GvHD). This study will also evaluate effectiveness of Ofatumumab when added to standard steroid treatment for chronic graft-versus-host disease
Detailed Summary: This is a phase I-II trial to examine the safety and efficacy of prednisone and escalating dose of ofatumumab for the primary therapy of chronic GVHD.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Current Primary Outcome: Occurrence of Dose Limiting Toxicities [ Time Frame: within 28 days of initiation ]
Original Primary Outcome: Number of participants with dose limiting toxicities [ Time Frame: within 28 days of initiation ]
Current Secondary Outcome: Participants Response Rates [ Time Frame: 6 months following initiation of Ofatumumab ]
Original Secondary Outcome: Same as current
Information By: H. Lee Moffitt Cancer Center and Research Institute
Dates:
Date Received: September 4, 2012
Date Started: November 2012
Date Completion: December 2017
Last Updated: December 13, 2016
Last Verified: December 2016