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

Leukemia Clinical Trial

Official title:

Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00898118
• Other study ID #: EWOG-MDS-SCT RC RIC-06
• Secondary ID: CDR0000587523EU-
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 9, 2013
• Start date: April 2007

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Genetic:
• polymerase chain reaction

Other:
• flow cytometry

• laboratory biomarker analysis

Procedure:
• allogeneic hematopoietic stem cell transplantation

Locations

Country	Name	City	State
Austria	St. Anna Children's Hospital	Vienna
Belgium	Ghent University	Ghent
Czech Republic	University Hospital Motol	Prague
Denmark	Aarhus Universitetshospital - Aarhus Sygehus	Aarhus
Germany	European Working Group of MDS in Childhood	Freiburg
Germany	Universitaetskinderklinik - Universitaetsklinikum Freiburg	Freiburg
Italy	IRCCS "Casa Sollievo della Sofferenza"	South Giovanni Rotondo
Netherlands	Erasmus MC - Sophia Children's Hospital	Rotterdam
Poland	Akademia Medyczna im. Piastow Slaskich	Wroclaw
Switzerland	University Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
European Working Group of MDS in Childhood

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Denmark,  Germany,  Italy,  Netherlands,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations			No
Primary	Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations			No
Secondary	Number of patients with mixed chimerism and full hematological recovery at day 100			No
Secondary	Number of patients with mixed chimerism and acute or chronic graft-versus-host disease			No