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

Purpose

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.

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:

MedlinePlus related topics: Leukemia

U.S. FDA Resources

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

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:

Eyrich M, Wollny G, Tzaribaschev N, Dietz K, Brugger D, Bader P, Lang P, Schilbach K, Winkler B, Niethammer D, Schlegel PG. Onset of thymic recovery and plateau of thymic output are differentially regulated after stem cell transplantation in children. Biol Blood Marrow Transplant. 2005 Mar;11(3):194-205.

Eyrich M, Leiler C, Lang P, Schilbach K, Schumm M, Bader P, Greil J, Klingebiel T, Handgretinger R, Niethammer D, Schlegel PG. A prospective comparison of immune reconstitution in pediatric recipients of positively selected CD34+ peripheral blood stem cells from unrelated donors vs recipients of unmanipulated bone marrow from related donors. Bone Marrow Transplant. 2003 Aug;32(4):379-90.

Eyrich M, Croner T, Leiler C, Lang P, Bader P, Klingebiel T, Niethammer D, Schlegel PG. Distinct contributions of CD4(+) and CD8(+) naive and memory T-cell subsets to overall T-cell-receptor repertoire complexity following transplantation of T-cell-depleted CD34-selected hematopoietic progenitor cells from unrelated donors. Blood. 2002 Sep 1;100(5):1915-8.

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:

Leukemia
Medulloblastoma
Neoplasms by Histologic Type
Neoplasms
Glioma
Neoplasms, Neuroepithelial

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 21, 2013

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