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

H

Hospital Universitario Dr. Jose E. Gonzalez

Status

Completed

Conditions

Graft vs Host Disease

Treatments

Drug: Alemtuzumab and rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT01042509
HE09-013

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Alemtuzumab and rituximab
Experimental group
Description:
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.
Treatment:
Drug: Alemtuzumab and rituximab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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