NCT01680965

Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease

Ofatumumab in Combination With Glucocorticoids for Primary Therapy of Chronic Graft Versus Host Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Ofatumumab	Phase I: test an escalating dose of ofatumumab at cohorts of 300 mg, 700 mg, and 1000 mg given on day 0 and 14 of study. Phase II: Ofatumumab MTD on day 0 and 14; patients will be followed for total of 24 months (months 1, 3, 6, 12 after therapy, then at 18 and 24 months following therapy)

Timeline

• Start date: 2012-11-14
• Primary completion: 2020-08-01
• Completion: 2020-08-30
• First posted: 2012-09-07
• Last updated: 2022-10-06
• Results posted: 2020-11-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study