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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 30, 2005

Last Updated Date

August 22, 2006

Start Date ^ICMJE

March 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00231712 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective Analysis of the Patterns of Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Autologous/Allogeneic Stem Cell Transplant

Brief Summary

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

conventional chemotherapy
high-dose chemotherapy followed by autologous stem cell transplant
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.

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Leukemia
Medulloblastoma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00231712

Other Study ID Numbers ^ICMJE

133/04

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Julius-Maximilians University

Collaborators ^ICMJE

University of Wuerzburg

Investigators ^ICMJE

Principal Investigator:	Paul G Schlegel, MD	University Children's Hospital Pediatric Oncology Wuerzburg / Germany
Study Director:	Matthias Eyrich, MD	Pediatric Stem Cell Transplant Program

Information Provided By

Julius-Maximilians University

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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