Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
NCT ID: NCT00898118
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
125 participants
OBSERVATIONAL
2007-04-30
Brief Summary
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PURPOSE: This research study is looking at blood samples in young patients with cytopenia after undergoing a donor stem cell transplant.
Detailed Description
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Primary
* To study hematopoietic chimerism in whole blood and different cell populations (i.e., CD14, CD15, CD 56, CD3, and CD19) as well as in dendritic cells and regulatory T cells after allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning in patients with refractory cytopenia.
* To compare the results of chimerism obtained with standard short tandem nucleotide polymorphism PCR (sensitivity 1%) with those obtained with single nucleotide polymorphisms PCR (sensitivity 0.1- 0.01%).
Secondary
* To evaluate the relationship between mixed chimerism and hematological engraftment, overall survival, and event-free survival.
* To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T cells on the incidence of acute and chronic graft-versus-host-disease.
OUTLINE: This is a multicenter study.
Peripheral blood is collected from patients and donors prior to hematopoietic stem cell transplantation (HSCT). Patients also undergo blood sample collection on days 30, 60, 100, and 180 after transplantation. Peripheral blood cells are enriched and separated into lineage-specific subpopulations (i.e., CD3, CD14, CD15, CD19, and CD56) which are then divided equally for either DNA isolation via PCR or for flow cytometry. DNA concentrations in pre-HSCT donor and patient samples and in post-HSCT subpopulation samples are determined using quantitative real-time PCR. Samples are also analyzed for quantification of chimerism and detection of genetic markers via short tandem repeats- and sequence nucleotide polymorphism-based chimerism analyses.
Conditions
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Keywords
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Interventions
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polymerase chain reaction
flow cytometry
laboratory biomarker analysis
allogeneic hematopoietic stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with refractory cytopenia
* Hypocellular bone marrow and normal karyotype
* Underwent stem cell transplantation (SCT) from an HLA identical (8/8) sibling, an HLA identical (10/10) relative, or an HLA identical or single allelic disparate unrelated donor
* Received a preparative regimen including either thiotepa or fludarabine phosphate
* Concurrently enrolled on EWOG-MDS-2006
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
17 Years
ALL
No
Sponsors
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European Working Group of MDS in Childhood
OTHER
Principal Investigators
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Peter Bader, MD
Role: PRINCIPAL_INVESTIGATOR
European Working Group of MDS in Childhood
Locations
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St. Anna Children's Hospital
Vienna, , Austria
Ghent University
Ghent, , Belgium
University Hospital Motol
Prague, , Czechia
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, , Denmark
European Working Group of MDS in Childhood
Freiburg im Breisgau, , Germany
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
IRCCS "Casa Sollievo della Sofferenza"
South Giovanni Rotondo, , Italy
Erasmus MC - Sophia Children's Hospital
Rotterdam, , Netherlands
Akademia Medyczna im. Piastow Slaskich
Wroclaw, , Poland
University Children's Hospital
Zurich, , Switzerland
Countries
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Facility Contacts
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Contact Person
Role: primary
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Contact
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Other Identifiers
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CDR0000587523
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20808
Identifier Type: -
Identifier Source: secondary_id
EWOG-MDS-SCT RC RIC-06
Identifier Type: -
Identifier Source: org_study_id