Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease — LowAR  

Graft vs Host Disease Clinical Trial

Official title: Combination of Alemtuzumab (Anti-CD52) and Rituximab (Anti-CD20) at Low-doses in Chronic Graft Versus Host Disease Treatment After First-line Therapy Failure.

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after first-line therapy failure.

Clinical Trial Description

Graft-versus-host disease (GVHD) is the most common long-term complication in patients who underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on immunosuppressive agents (usually cyclosporine and corticosteroids) achieving satisfactory response in around 30% of patients. There is no ideal second-line treatment for chronic GVHD; however, numerous studies have been published with therapeutic options such as alemtuzumab (anti-CD52) and rituximab (anti-CD20).

This is a prospective, longitudinal, nonrandomized study in which alemtuzumab and rituximab will be administered at low-doses to patients with refractory chronic GVHD. Clinical response will be evaluated based on the Working Group Report 2006, published by the National Institute of Health Consensus. Follow-up sessions will be weekly for four weeks, every two weeks until achieve response, and finally every four weeks. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease

• NCT number: NCT01042509
• Study type: Interventional
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Miguel A Gomez-Guijosa, M.D.
• Phone: +52 81 83 48 61 36
• Email: magg770214@yahoo.com.mx
• Status: Recruiting
• Phase: N/A
• Start date: October 2009
• Completion date: January 2011