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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.
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01042509
First received: January 4, 2010
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
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 David Gomez Almaguer, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042509

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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Gomez Almaguer, Dr., Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov 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 David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez:
Chronic Graft vs Host Disease
Alemtuzumab
Rituximab
Low-dose
Alemtuzumab and rituximab combination

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Alemtuzumab
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 25, 2017