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

This study has been completed.
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez Identifier:
First received: January 4, 2010
Last updated: December 7, 2016
Last verified: December 2016
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.

Condition Intervention
Graft vs Host Disease
Drug: Alemtuzumab and rituximab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Side Effects [ Time Frame: 365 days ]
    Percentage of participants who experienced side effects

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Alemtuzumab and rituximab
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
Other Names:
  • Campath
  • Rituxan

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01042509

Hematology Department of Hospital Universitario Dr Jose E Gonzalez
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Principal Investigator: David Gomez-Almaguer, M.D. Hospital Universitario Dr. Jose E. Gonzalez
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Gomez Almaguer, Dr., Hospital Universitario Dr. Jose E. Gonzalez Identifier: NCT01042509     History of Changes
Other Study ID Numbers: HE09-013
Study First Received: January 4, 2010
Results First Received: February 16, 2012
Last Updated: December 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Chronic Graft vs Host Disease
Alemtuzumab and rituximab combination

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on April 24, 2017