Combination of Alemtuzumab (Anti-CD52) and Rituximab (Anti-CD20) at Low-doses in Chronic Graft Versus Host Disease Treatment After First-line Therapy Failure.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Alemtuzumab and rituximab (Drug)
Outcomes
Primary Outcomes
Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.
Time Frame: 30, 90 and 365 days
Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up
Secondary Outcomes
- Side Effects(365 days)
Investigators
David Gomez Almaguer
Dr.
Hospital Universitario Dr. Jose E. Gonzalez