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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00231712
• Other study ID #: 133/04
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2005
• Last updated: August 22, 2006
• Start date: March 2005
• Est. completion date: February 2009

Study information

• Verified date: September 2005
• Source: Julius-Maximilians University
• Contact: Paul G Schlegel, MD
• Phone: +49 - 931 - 201 - 27831
• Email: schlegel[@]mail.uni-wuerzburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Leukemia
• Medulloblastoma

Locations

Country	Name	City	State
Germany	University Children's Hospital Pedaitric Oncology	Wuerzburg

Sponsors (2)

Lead Sponsor	Collaborator
Julius-Maximilians University	University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View Citation

Eyrich M, Wollny G, Tzaribaschev N, Dietz K, Brügger 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. — View Citation