Clinical trial NCT00231712: Immuno 1: Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Stem Cell Transplant
Official title: Prospective Analysis of the Patterns of Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Autologous/Allogeneic Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Medulloblastoma
Keywords: prospective analysis of immune function,
spectratype
immunoscope
TREC analysis
solid tumor
Lead sponsor: Julius-Maximilians University
Sponsor class: OTHER
Collaborators: name: University of Wuerzburg
First posted: 2005-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Children's Hospital Pedaitric Oncology
Study officials:
affiliation: University Children's Hospital Pediatric Oncology Wuerzburg / Germany
name: Paul G Schlegel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Stem Cell Transplant Program
name: Matthias Eyrich, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.bbmt.2004.12.001.
citation: 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. doi: 10.1038/sj.bmt.1704158.
citation: 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. doi: 10.1182/blood-2001-11-0005.