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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 9, 2009
Last updated: August 9, 2013
Last verified: April 2008

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 Intervention
Myelodysplastic Syndromes
Genetic: polymerase chain reaction
Other: flow cytometry
Other: laboratory biomarker analysis
Procedure: allogeneic hematopoietic stem cell transplantation

Study Type: Observational
Official Title: Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations [ Designated as safety issue: No ]
  • Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with mixed chimerism and full hematological recovery at day 100 [ Designated as safety issue: No ]
  • Number of patients with mixed chimerism and acute or chronic graft-versus-host disease [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: April 2007
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00898118

St. Anna Children's Hospital
Vienna, Austria, A-1090
Ghent University
Ghent, Belgium, B-9000
Czech Republic
University Hospital Motol
Prague, Czech Republic, 150 06
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, Denmark, DK-8000
European Working Group of MDS in Childhood
Freiburg, Germany, 79106
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg, Germany, D-79106
IRCCS "Casa Sollievo della Sofferenza"
South Giovanni Rotondo, Italy, 71013
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands, 3015 GJ
Akademia Medyczna im. Piastow Slaskich
Wroclaw, Poland, 50-367
University Children's Hospital
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
European Working Group of MDS in Childhood
Principal Investigator: Peter Bader, MD European Working Group of MDS in Childhood
  More Information Identifier: NCT00898118     History of Changes
Other Study ID Numbers: EWOG-MDS-SCT RC RIC-06  CDR0000587523  EU-20808 
Study First Received: May 9, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

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:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms processed this record on December 09, 2016