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

NCT ID: NCT00587574

Last Updated: 2008-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-12-31

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.

Conditions

Allogeneic Hematopoietic Cell Transplant Recipients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

I

Chronic graft-versus-host disease

No interventions assigned to this group

II

No chronic graft-versus-host disease

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Vienna

Principal Investigators

Hildegard T Greinix, Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Institute of Hematology and Blood Transfusions Prague

Prague, , Czechia

Site Status: ACTIVE_NOT_RECRUITING

Countries

Austria; Czechia

Central Contacts

Hildegard T Greinix, Professor

Role: CONTACT

hildegard.greinix@meduniwien.ac.at

+43140400 ext. 4457

Winfried Pickl, Professor

Role: CONTACT

winfried.pickl@meduniwien.ac.at

+434277 ext. 64945

Facility Contacts

Hildegard T Greinix, Professor

Role: primary

hildegard.greinix@meduniwien.ac.at

+43140400 ext. 4457

Other Identifiers

EK Nr 488/2007

Identifier Type: -

Identifier Source: secondary_id

488/2007

Identifier Type: -

Identifier Source: org_study_id