Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
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|ClinicalTrials.gov 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
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|
- 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.
|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|
- Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations
- Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations
- Number of patients with mixed chimerism and full hematological recovery at day 100
- Number of patients with mixed chimerism and acute or chronic graft-versus-host disease
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 ClinicalTrials.gov identifier (NCT number): NCT00898118
|St. Anna Children's Hospital||Recruiting|
|Vienna, Austria, A-1090|
|Contact: Contact Person 43-1-401-700 firstname.lastname@example.org|
|Ghent, Belgium, B-9000|
|Contact: Contact Person 32-9240-3875 email@example.com|
|University Hospital Motol||Recruiting|
|Prague, Czech Republic, 150 06|
|Contact: Contact Person 42-022-443-6401 firstname.lastname@example.org|
|Aarhus Universitetshospital - Aarhus Sygehus||Recruiting|
|Aarhus, Denmark, DK-8000|
|Contact: Contact Person 45-8949-6841 email@example.com|
|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 firstname.lastname@example.org|
|IRCCS "Casa Sollievo della Sofferenza"||Recruiting|
|South Giovanni Rotondo, Italy, 71013|
|Contact: Contact person 39-038-250-1251 email@example.com|
|Erasmus MC - Sophia Children's Hospital||Recruiting|
|Rotterdam, Netherlands, 3015 GJ|
|Contact: Contact Person 31-104-636-691 firstname.lastname@example.org|
|Akademia Medyczna im. Piastow Slaskich||Recruiting|
|Wroclaw, Poland, 50-367|
|Contact: Contact Person 48-71-328-2040 email@example.com|
|University Children's Hospital||Recruiting|
|Zurich, Switzerland, CH-8032|
|Contact: Contact Person 41-44-266-7723 firstname.lastname@example.org|
|Principal Investigator:||Peter Bader, MD||European Working Group of MDS in Childhood|