Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
Primary Purpose
Leukemia, Myelodysplastic Syndromes
Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
polymerase chain reaction
flow cytometry
laboratory biomarker analysis
allogeneic hematopoietic stem cell transplantation
Sponsored by
About this trial
This is an observational trial for Leukemia focused on measuring refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
Eligibility 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
Sites / Locations
- St. Anna Children's HospitalRecruiting
- Ghent UniversityRecruiting
- University Hospital MotolRecruiting
- Aarhus Universitetshospital - Aarhus SygehusRecruiting
- European Working Group of MDS in ChildhoodRecruiting
- Universitaetskinderklinik - Universitaetsklinikum FreiburgRecruiting
- IRCCS "Casa Sollievo della Sofferenza"Recruiting
- Erasmus MC - Sophia Children's HospitalRecruiting
- Akademia Medyczna im. Piastow SlaskichRecruiting
- University Children's HospitalRecruiting
Outcomes
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
Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00898118
First Posted
May 9, 2009
Last Updated
August 9, 2013
Sponsor
European Working Group of MDS in Childhood
1. Study Identification
Unique Protocol Identification Number
NCT00898118
Brief Title
Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
Official Title
Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)
Study Type
Observational
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
European Working Group of MDS in Childhood
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
7. Study Design
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
allogeneic hematopoietic stem cell transplantation
Primary Outcome Measure Information:
Title
Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations
Title
Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations
Secondary Outcome Measure Information:
Title
Number of patients with mixed chimerism and full hematological recovery at day 100
Title
Number of patients with mixed chimerism and acute or chronic graft-versus-host disease
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bader, MD
Organizational Affiliation
European Working Group of MDS in Childhood
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Anna Children's Hospital
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
43-1-401-700
Email
trebo@ccri.univie.ac.at
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
32-9240-3875
Email
barbara.demoerloose@ugent.be
Facility Name
University Hospital Motol
City
Prague
ZIP/Postal Code
150 06
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
42-022-443-6401
Email
jan.stary@lfmotol.cuni.cz
Facility Name
Aarhus Universitetshospital - Aarhus Sygehus
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
45-8949-6841
Email
hasle@dadlnet.dk
Facility Name
European Working Group of MDS in Childhood
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact
Phone
49-761-270-4617
Email
Peter.Bader@kgu.de
Facility Name
Universitaetskinderklinik - Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-761-270-4506
Email
ewog-mds@uniklini-freiburg.de
Facility Name
IRCCS "Casa Sollievo della Sofferenza"
City
South Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact person
Phone
39-038-250-1251
Email
m.zecca@smatteo.pv.it
Facility Name
Erasmus MC - Sophia Children's Hospital
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
31-104-636-691
Email
m.vandenheuvel@erasmusmc.nl
Facility Name
Akademia Medyczna im. Piastow Slaskich
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
48-71-328-2040
Email
wojcikd@pedhemat.am.wroc.pl
Facility Name
University Children's Hospital
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
41-44-266-7723
Email
eva.bergstraesser@kispi.unizh.ch
12. IPD Sharing Statement
Learn more about this trial
Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
We'll reach out to this number within 24 hrs