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Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00898118
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 12, 2009
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples in young patients with cytopenia after undergoing a donor stem cell transplant.

Condition or disease Intervention/treatment
Leukemia Myelodysplastic Syndromes Genetic: polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis Procedure: allogeneic hematopoietic stem cell transplantation

Detailed Description:



  • 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%).


  • 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.

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Study Type : Observational
Estimated Enrollment : 125 participants
Official Title: Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)
Study Start Date : April 2007
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations
  2. Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations

Secondary Outcome Measures :
  1. Number of patients with mixed chimerism and full hematological recovery at day 100
  2. Number of patients with mixed chimerism and acute or chronic graft-versus-host disease

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00898118

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St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Contact Person    43-1-401-700   
Ghent University Recruiting
Ghent, Belgium, B-9000
Contact: Contact Person    32-9240-3875   
Czech Republic
University Hospital Motol Recruiting
Prague, Czech Republic, 150 06
Contact: Contact Person    42-022-443-6401   
Aarhus Universitetshospital - Aarhus Sygehus Recruiting
Aarhus, Denmark, DK-8000
Contact: Contact Person    45-8949-6841   
European Working Group of MDS in Childhood Recruiting
Freiburg, Germany, 79106
Contact: Contact    49-761-270-4617   
Universitaetskinderklinik - Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, D-79106
Contact: Contact Person    49-761-270-4506   
IRCCS "Casa Sollievo della Sofferenza" Recruiting
South Giovanni Rotondo, Italy, 71013
Contact: Contact person    39-038-250-1251   
Erasmus MC - Sophia Children's Hospital Recruiting
Rotterdam, Netherlands, 3015 GJ
Contact: Contact Person    31-104-636-691   
Akademia Medyczna im. Piastow Slaskich Recruiting
Wroclaw, Poland, 50-367
Contact: Contact Person    48-71-328-2040   
University Children's Hospital Recruiting
Zurich, Switzerland, CH-8032
Contact: Contact Person    41-44-266-7723   
Sponsors and Collaborators
European Working Group of MDS in Childhood
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Principal Investigator: Peter Bader, MD European Working Group of MDS in Childhood
Layout table for additonal information Identifier: NCT00898118    
Other Study ID Numbers: EWOG-MDS-SCT RC RIC-06
CDR0000587523 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: April 2008
Keywords provided by National Cancer Institute (NCI):
refractory cytopenia with multilineage dysplasia
childhood myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions