Combination of Alemtuzumab (Anti-CD52) and Rituximab (Anti-CD20) at Low-doses in Chronic Graft Versus Host Disease Treatment After First-line Therapy Failure.
18 Years
65 Years
Both
Graft vs Host Disease
Trial Information
Combination of Alemtuzumab (Anti-CD52) and Rituximab (Anti-CD20) at Low-doses in Chronic Graft Versus Host Disease Treatment After First-line Therapy Failure.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate clinical response of alemtuzumab and rituximab combination in patients with refractory chronic GVHD based on the Working Group Report 2006.
Outcome Time Frame:
90 days and 1 year
Safety Issue:
Yes
Principal Investigator
David Gomez-Almaguer, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Universitario Dr. Jose E. Gonzalez
Authority:
Mexico: Ethics Committee
Study ID:
HE09-013
NCT ID:
NCT01042509
Start Date:
October 2009
Completion Date:
January 2011
Related Keywords:
- Graft Vs Host Disease
- Chronic Graft vs Host Disease
- Alemtuzumab
- Rituximab
- Low-dose
- Alemtuzumab and rituximab combination
- Graft vs Host Disease
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