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

• Conditions: Leukemia; Myelodysplastic Syndromes

• Registration Number: NCT00898118
• Lead Sponsor: European Working Group of MDS in Childhood

Brief Summary

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.

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 Timeline

• Study Start: 2007-04
• Status Verified: 2008-04
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2013-03
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (10)

Ghent University; 🇧🇪 Ghent, Belgium

European Working Group of MDS in Childhood; 🇩🇪 Freiburg, Germany

University Hospital Motol; 🇨🇿 Prague, Czech Republic

St. Anna Children's Hospital; 🇦🇹 Vienna, Austria

IRCCS "Casa Sollievo della Sofferenza"; 🇮🇹 South Giovanni Rotondo, Italy

Erasmus MC - Sophia Children's Hospital; 🇳🇱 Rotterdam, Netherlands

Aarhus Universitetshospital - Aarhus Sygehus; 🇩🇰 Aarhus, Denmark

Universitaetskinderklinik - Universitaetsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Akademia Medyczna im. Piastow Slaskich; 🇵🇱 Wroclaw, Poland

University Children's Hospital; 🇨🇭 Zurich, Switzerland