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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898118
First received: May 9, 2009
Last updated: August 9, 2013
Last verified: April 2008
  Purpose

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
Leukemia
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:

OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  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 ClinicalTrials.gov identifier: NCT00898118

Locations
Austria
St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Contact Person    43-1-401-700    trebo@ccri.univie.ac.at   
Belgium
Ghent University Recruiting
Ghent, Belgium, B-9000
Contact: Contact Person    32-9240-3875    barbara.demoerloose@ugent.be   
Czech Republic
University Hospital Motol Recruiting
Prague, Czech Republic, 150 06
Contact: Contact Person    42-022-443-6401    jan.stary@lfmotol.cuni.cz   
Denmark
Aarhus Universitetshospital - Aarhus Sygehus Recruiting
Aarhus, Denmark, DK-8000
Contact: Contact Person    45-8949-6841    hasle@dadlnet.dk   
Germany
European Working Group of MDS in Childhood Recruiting
Freiburg, Germany, 79106
Contact: Contact    49-761-270-4617    Peter.Bader@kgu.de   
Universitaetskinderklinik - Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, D-79106
Contact: Contact Person    49-761-270-4506    ewog-mds@uniklini-freiburg.de   
Italy
IRCCS "Casa Sollievo della Sofferenza" Recruiting
South Giovanni Rotondo, Italy, 71013
Contact: Contact person    39-038-250-1251    m.zecca@smatteo.pv.it   
Netherlands
Erasmus MC - Sophia Children's Hospital Recruiting
Rotterdam, Netherlands, 3015 GJ
Contact: Contact Person    31-104-636-691    m.vandenheuvel@erasmusmc.nl   
Poland
Akademia Medyczna im. Piastow Slaskich Recruiting
Wroclaw, Poland, 50-367
Contact: Contact Person    48-71-328-2040    wojcikd@pedhemat.am.wroc.pl   
Switzerland
University Children's Hospital Recruiting
Zurich, Switzerland, CH-8032
Contact: Contact Person    41-44-266-7723    eva.bergstraesser@kispi.unizh.ch   
Sponsors and Collaborators
European Working Group of MDS in Childhood
Investigators
Principal Investigator: Peter Bader, MD European Working Group of MDS in Childhood
  More Information

No publications provided

ClinicalTrials.gov 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
Preleukemia
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014