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

August 9, 2013 updated by: European Working Group of MDS in Childhood

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Recruiting
        • St. Anna Children's Hospital
        • Contact:
  • Belgium
  • Czech Republic
      • Prague, Czech Republic, 150 06
        • Recruiting
        • University Hospital Motol
        • Contact:
  • Denmark
      • Aarhus, Denmark, DK-8000
        • Recruiting
        • Aarhus Universitetshospital - Aarhus Sygehus
        • Contact:
  • Germany
      • Freiburg, Germany, D-79106
        • Recruiting
        • Universitaetskinderklinik - Universitaetsklinikum Freiburg
        • Contact:
      • Freiburg, Germany, 79106
        • Recruiting
        • European Working Group of MDS in Childhood
        • Contact:
  • Italy
      • South Giovanni Rotondo, Italy, 71013
        • Recruiting
        • IRCCS "Casa Sollievo della Sofferenza"
        • Contact:
  • Netherlands
      • Rotterdam, Netherlands, 3015 GJ
        • Recruiting
        • Erasmus MC - Sophia Children's Hospital
        • Contact:
  • Poland
      • Wroclaw, Poland, 50-367
        • Recruiting
        • Akademia Medyczna im. Piastow Slaskich
        • Contact:
  • Switzerland
      • Zurich, Switzerland, CH-8032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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
Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Working Group of MDS in Childhood

Investigators

  • Principal Investigator: Peter Bader, MD, European Working Group of MDS in Childhood

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EWOG-MDS-SCT RC RIC-06
  • CDR0000587523 (REGISTRY: PDQ (Physician Data Query))
  • EU-20808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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