LeukemiaNCT00898118
Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
An observational study of Leukemia and Myelodysplastic Syndromes, run by European Working Group of MDS in Childhood at 10 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- polymerase chain reaction, flow cytometry and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 10 sitesin 9 countries
- Study dates
- Apr 2007to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
Germany2 sites, 2 recruiting
- Recruiting
European Working Group of MDS in Childhood
Freiburg im Breisgau, 79106
Contact, 49-761-270-4617, Peter.Bader@kgu.de
- Recruiting
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, D-79106
Contact Person, 49-761-270-4506, ewog-mds@uniklini-freiburg.de
Austria1 site, 1 recruiting
- Recruiting
St. Anna Children's Hospital
Vienna, A-1090
Contact Person, 43-1-401-700, trebo@ccri.univie.ac.at
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, B-9000
Contact Person, 32-9240-3875, barbara.demoerloose@ugent.be
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Motol
Prague, 150 06
Contact Person, 42-022-443-6401, jan.stary@lfmotol.cuni.cz
Denmark1 site, 1 recruiting
- Recruiting
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, DK-8000
Contact Person, 45-8949-6841, hasle@dadlnet.dk
Italy1 site, 1 recruiting
- Recruiting
IRCCS "Casa Sollievo della Sofferenza"
South Giovanni Rotondo, 71013
Contact person, 39-038-250-1251, m.zecca@smatteo.pv.it
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC - Sophia Children's Hospital
Rotterdam, 3015 GJ
Contact Person, 31-104-636-691, m.vandenheuvel@erasmusmc.nl
Poland1 site, 1 recruiting
- Recruiting
Akademia Medyczna im. Piastow Slaskich
Wroclaw, 50-367
Contact Person, 48-71-328-2040, wojcikd@pedhemat.am.wroc.pl
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital
Zurich, CH-8032
Contact Person, 41-44-266-7723, eva.bergstraesser@kispi.unizh.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- polymerase chain reaction, flow cytometry, laboratory biomarker analysis, allogeneic hematopoietic stem cell transplantation
- Keywords
- refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymerase chain reactionGenetic
flow cytometryOther
laboratory biomarker analysisOther
allogeneic hematopoietic stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2007
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Working Group of MDS in Childhood
- Sponsor type
- University, hospital or other
- Investigators
- Peter Bader, MD, Principal investigator, European Working Group of MDS in Childhood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898118
- Sponsor's protocol ID
- EWOG-MDS-SCT RC RIC-06
- Other IDs
- CDR0000587523, EU-20808
- Status last verified
- Apr 2008
- First submitted
- 9 May 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)
- ClinicalTrials.gov ID
- NCT00898118
- Acronym / sponsor ID
- EWOG-MDS-SCT RC RIC-06
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- European Working Group of MDS in ChildhoodUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2013 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polymerase chain reaction | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
| allogeneic hematopoietic stem cell transplantation | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bader, MD principal investigator
European Working Group of MDS in Childhood
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Myelodysplastic Syndromes, run by European Working Group of MDS in Childhood at 10 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria, Belgium, Czechia, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.