Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic HSCT

• Conditions: Allogeneic Hematopoietic Cell Transplant Recipients

• Registration Number: NCT00587574
• Lead Sponsor: Medical University of Vienna

Brief Summary

Allogeneic hematopoietic cell transplantation offers high cure rates for patients with hematological and oncological diseases. Graft-versus-host disease (attack of donor's white blood cells on patient's tissues) is a serious complication also affecting the patient's immune system. Therefore, patients in the early phase after allogeneic cell transplantation are at high risk for severe infectious complications. So far, no predictive biomarkers for the development of the chronic form of graft-versus-host disease are available. By analysing serially immune cell populations of the peripheral blood we will investigate whether certain subsets of cells are associated with development of chronic graft-versus-host disease. In addition, the patients' immune regeneration will be evaluated by serial analyses of peripheral blood immune cell populations 3 months to 2 years after allogeneic cell transplantation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-10
• Study Start: 2007-10
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-04
• Last Update Submitted: 2008-01-04
• Study First Posted: 2008-01-07
• Last Update Posted: 2008-01-07
• Primary Completion: 2010-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Receiving grafts from either HLA-identical sibling donors or HLA-matched unrelated donors
• Receiving grafts from HLA-mismatched sibling donors or HLA-mismatched unrelated donors
• Receiving either bone marrow, peripheral blood stem cells or cord blood grafts
• Alive on day 100 after transplant
• Age 18 years or above
• Signed written informed consent

Exclusion Criteria

• Lymphocytopenia not allowing immunophenotyping
• Treatment with rituximab after HSCT until study entry
• Hepatitis B and C, HIV infection
• Secondary posttransplant malignancies including EBV-lymphoproliferative disease
• Karnofsky score of 30 or below
• Absence of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system	October 2007 until December 2010

Secondary Outcome Measures

Name	Time	Method
Compare the number of circulating T, DC, NK subsets in patients with and without chronic GVHD to identify their respective role in development and prolongation of chronic GVHD	October 2007 until December 2010
Investigate the impact of different immunosuppressive/immunomodulatory treatments for chronic GVHD on various immune cell populations	October 2007 until December 2010
Compare number of clinically defined bacterial, viral and fungal infectious episodes between patients with and without chronic graft-versus-host disease	October 2007 until December 2010
Difference of time-dependent pattern of immune reconstitution after allogeneic cell transplantation between patients with and without chronic graft-versus-host disease	October 2010 until December 2010
Assess the chimerism of antigen-presenting cells in circulation and tissue specimens and correlate it with occurrence of chronic GVHD	October 2007 until December 2010

Trial Locations

Locations (2)

Medical University of Vienna; 🇦🇹 Vienna, Austria

Institute of Hematology and Blood Transfusions Prague; 🇨🇿 Prague, Czech Republic