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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231712
First Posted: October 4, 2005
Last Update Posted: August 23, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Wuerzburg
Information provided by:
Julius-Maximilians University
  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
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 30, 2005
First Posted: October 4, 2005
Last Update Posted: August 23, 2006
Last Verified: September 2005

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