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

Not Applicable

Completed

• Conditions: Graft vs Host Disease
• Interventions: Drug: Alemtuzumab and rituximab

• Registration Number: NCT01042509
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Results First Submitted: 2012-02-16
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-07
• Last Update Submitted: 2016-12-07
• Results First Posted: 2017-02-01
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients with chronic graft-versus-host disease.
• Patients over 18 years old.
• Patients who received first-line treatment with no response (failure), relapse or steroid dependance.

Exclusion Criteria

• Patients with active bacterial or viral infections.
• Patients with hematologic disease progression.
• Patient's intolerance to drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alemtuzumab and rituximab	Alemtuzumab and rituximab	Patients with chronic GVHD after first-line therapy failure will receive Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25. THE STUDY HAVE ONLY ONE ARM.

Primary Outcome Measures

Name	Time	Method
Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.	30, 90 and 365 days	Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up

Secondary Outcome Measures

Name	Time	Method
Side Effects	365 days	Percentage of participants who experienced side effects

Trial Locations

Locations (1)

Hematology Department of Hospital Universitario Dr Jose E Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico