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

May 9, 2009
August 9, 2013
April 2007
March 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00898118 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)

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.

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.

Observational
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  • Leukemia
  • Myelodysplastic Syndromes
  • Genetic: polymerase chain reaction
  • Other: flow cytometry
  • Other: laboratory biomarker analysis
  • Procedure: allogeneic hematopoietic stem cell transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
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March 2013   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Austria,   Belgium,   Czech Republic,   Denmark,   Germany,   Italy,   Netherlands,   Poland,   Switzerland
 
NCT00898118
EWOG-MDS-SCT RC RIC-06, CDR0000587523, EU-20808
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European Working Group of MDS in Childhood
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Principal Investigator: Peter Bader, MD European Working Group of MDS in Childhood
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP