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 ]

The dose limiting toxicity (DLT) will be Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 defined grade 4 adverse events attributable to the study agent ofatumumab


Original Primary Outcome: Number of participants with dose limiting toxicities [ Time Frame: within 28 days of initiation ]

The dose limiting toxicity (DLT) will be CTCAE version 4.0 defined grade 4 adverse events attributable to the study agent ofatumumab


Current Secondary Outcome: Participants Response Rates [ Time Frame: 6 months following initiation of Ofatumumab ]

Overall response rate (ORR) at 6 months following initiation of therapy represents the composite outcome of complete and partial response


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