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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Julius-Maximilians University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Wuerzburg
Information provided by:
Julius-Maximilians University
ClinicalTrials.gov Identifier:
NCT00231712
First received: September 30, 2005
Last updated: August 22, 2006
Last verified: September 2005
  Purpose

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.


Condition
Leukemia
Medulloblastoma

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231712

Contacts
Contact: Paul G Schlegel, MD +49 - 931 - 201 - 27831 schlegel@mail.uni-wuerzburg.de
Contact: Beate Winkler, MD 49 - 931 - 201 - 27831 winkler_b@klinik.uni-wuerzburg.de

Locations
Germany
University Children's Hospital Pedaitric Oncology Recruiting
Wuerzburg, Germany, D97080
Contact: Beate Winkler, MD    49 - 931 - 201 - 27831    winkler_b@klinik.uni.wuerzburg.de   
Principal Investigator: Beate Winkler, MD         
Sponsors and Collaborators
Julius-Maximilians University
University of Wuerzburg
Investigators
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:
ClinicalTrials.gov Identifier: NCT00231712     History of Changes
Other Study ID Numbers: 133/04
Study First Received: September 30, 2005
Last Updated: August 22, 2006
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Medulloblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on September 16, 2014