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

NCT00682799 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2015-01-15

No results posted yet for this study

Summary

This is a prospective, non-randomized multi-center multi-national study to evaluate the chimerism measured by STR and SNP in patients with hypoplastic RC and normal karyotype transplanted with a preparative regimen of reduced intensity.

Primary objectives:

* To study hematopoietic chimerism in whole blood and different cell population (CD14, CD15, CD 56, CD3, CD19) as well as in dendritic cells and regulatory T-cells after SCT with RIC in patients with RC
* To compare the results of chimerism obtained with standard STR PCR (sensitivity 1%) with those obtained with SNP PCR (sensitivity 0.1- 0.01%)

Secondary objectives:

* To evaluate the relationship between mixed chimerism and hematological engraftment, OS and EFS
* To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T-cells on the incidence of acute and chronic GVHD

Conditions

  • Refractory Cytopenia of Childhood
  • Reduced Intensity Conditioning (RIC)
  • Myelodysplastic Syndrome (MDS)
  • Hematopoietic Stem Cell Transplantation (SCT)

Sponsors & Collaborators

  • Charlotte Niemeyer, MD

    lead OTHER

Principal Investigators

  • Peter Bader, M.D. · University Children´s Hospital Frankfurt am Main

Eligibility

Max Age
215 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682799 on ClinicalTrials.gov