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Immuno 1: Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Stem Cell Transplant

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Julius-Maximilians University.
Recruitment status was:  Recruiting
University of Wuerzburg
Information provided by:
Julius-Maximilians University Identifier:
First received: September 30, 2005
Last updated: August 22, 2006
Last verified: September 2005

The purpose of this study is to conduct an analysis of the influences of

  1. conventional chemotherapy
  2. high-dose chemotherapy followed by autologous stem cell transplant
  3. high-dose chemotherapy followed by allogeneic stem cell transplant on the recovery of the immune system.

Detailed analysis will help to better understand the pathways of recovery of the immune system following chemotherapy as well as the pathways of recovery of the immune system following autologous or allogeneic stem cell transplantation.


Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prospective Analysis of the Patterns of Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Autologous/Allogeneic Stem Cell Transplant

Resource links provided by NLM:

Further study details as provided by Julius-Maximilians University:

Estimated Enrollment: 50
Study Start Date: March 2005
Estimated Study Completion Date: February 2009
Detailed Description:

Detailed analysis will be performed at preselected time points following therapy by

  • standard flow cytometry in combination with intracellular cytokine/antigen staining
  • spectratype analysis
  • TREC assays

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute leukemia treated according to current ALL-BFM 2002 protocol
  • Solid tumor treated according to current GPOH-protocol
  • Medulloblastoma treated according to HIT-2000 protocol
  • High-dose chemotherapy followed by autologous stem cell transplantation
  • High-dose chemotherapy followed by allogeneic stem cell transplantation
  • Written consent according to our institutional guidelines

Exclusion Criteria:

  • No written consent
  Contacts and Locations
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Please refer to this study by its identifier: NCT00231712

Contact: Paul G Schlegel, MD +49 - 931 - 201 - 27831
Contact: Beate Winkler, MD 49 - 931 - 201 - 27831

University Children's Hospital Pedaitric Oncology Recruiting
Wuerzburg, Germany, D97080
Contact: Beate Winkler, MD    49 - 931 - 201 - 27831   
Principal Investigator: Beate Winkler, MD         
Sponsors and Collaborators
Julius-Maximilians University
University of Wuerzburg
Principal Investigator: Paul G Schlegel, MD University Children's Hospital Pediatric Oncology Wuerzburg / Germany
Study Director: Matthias Eyrich, MD Pediatric Stem Cell Transplant Program
  More Information

Publications: Identifier: NCT00231712     History of Changes
Other Study ID Numbers: 133/04
Study First Received: September 30, 2005
Last Updated: August 22, 2006

Keywords provided by Julius-Maximilians University:
prospective analysis of immune function,
TREC analysis
solid tumor

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue processed this record on May 24, 2017