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

January 4, 2008 updated by: Medical University of Vienna

Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic Hematopoietic Stem Cell Transplantation and Immunomodulatory Consequences of Chronic Graft-Versus-Host Disease and Therapy

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.

Study Overview

Status

Unknown

Conditions

Allogeneic Hematopoietic Cell Transplant Recipients

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Vienna, Austria, 1090
    - Recruiting
    - Medical University of Vienna
    - Contact:
      
      Hildegard T Greinix, Professor
      
      Phone Number: 4457 +43140400
      
      Email: hildegard.greinix@meduniwien.ac.at
    - Principal Investigator:
      
      Hildegard T Greinix, Professor
Czech Republic
- - Prague, Czech Republic
    - Active, not recruiting
    - Institute of Hematology and Blood Transfusions Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all consecutive patients after allogeneic hematopoietic cell transplantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
I Chronic graft-versus-host disease
II No chronic graft-versus-host disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system Time Frame: October 2007 until December 2010	October 2007 until December 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference of time-dependent pattern of immune reconstitution after allogeneic cell transplantation between patients with and without chronic graft-versus-host disease Time Frame: October 2010 until December 2010	October 2010 until December 2010
Compare number of clinically defined bacterial, viral and fungal infectious episodes between patients with and without chronic graft-versus-host disease Time Frame: October 2007 until December 2010	October 2007 until December 2010
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 Time Frame: October 2007 until December 2010	October 2007 until December 2010
Investigate the impact of different immunosuppressive/immunomodulatory treatments for chronic GVHD on various immune cell populations Time Frame: October 2007 until December 2010	October 2007 until December 2010
Assess the chimerism of antigen-presenting cells in circulation and tissue specimens and correlate it with occurrence of chronic GVHD Time Frame: October 2007 until December 2010	October 2007 until December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

Principal Investigator: Hildegard T Greinix, Professor, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 7, 2008

Study Record Updates

Last Update Posted (Estimate)