NCT00898118

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Geographic Reach
9 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

April 1, 2008

Enrollment Period

5.9 years

First QC Date

May 9, 2009

Last Update Submit

August 9, 2013

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

refractory cytopenia with multilineage dysplasiachildhood myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromes

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

polymerase chain reactionGENETIC
flow cytometryOTHER
laboratory biomarker analysisOTHER
allogeneic hematopoietic stem cell transplantationPROCEDURE

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

St. Anna Children's Hospital

Vienna, A-1090, Austria

RECRUITING

Ghent University

Ghent, B-9000, Belgium

RECRUITING

University Hospital Motol

Prague, 150 06, Czechia

RECRUITING

Aarhus Universitetshospital - Aarhus Sygehus

Aarhus, DK-8000, Denmark

RECRUITING

European Working Group of MDS in Childhood

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

RECRUITING

IRCCS "Casa Sollievo della Sofferenza"

South Giovanni Rotondo, 71013, Italy

RECRUITING

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

RECRUITING

Akademia Medyczna im. Piastow Slaskich

Wroclaw, 50-367, Poland

RECRUITING

University Children's Hospital

Zurich, CH-8032, Switzerland

RECRUITING

MeSH Terms

Conditions

LeukemiaMyelodysplastic Syndromes

Interventions

Polymerase Chain ReactionFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Peter Bader, MD

    European Working Group of MDS in Childhood

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2007

Primary Completion

March 1, 2013

Last Updated

August 12, 2013

Record last verified: 2008-04

Locations

DE(2)AU(1)BE(1)DK(1)IT(1)PL(1)CH(1)NL(1)CZ(1)