NCT00231712

Brief Summary

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

  1. 1.conventional chemotherapy
  2. 2.high-dose chemotherapy followed by autologous stem cell transplant
  3. 3.high-dose chemotherapy followed by allogeneic stem cell transplant on the recovery of the immune system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 23, 2006

Status Verified

September 1, 2005

First QC Date

September 30, 2005

Last Update Submit

August 22, 2006

Conditions

Keywords

prospective analysis of immune function,spectratypeimmunoscopeTREC analysissolid tumor

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Pedaitric Oncology

Würzburg, D97080, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15744238BACKGROUND
  • 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.

    PMID: 12900774BACKGROUND
  • 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.

    PMID: 12176918BACKGROUND

MeSH Terms

Conditions

LeukemiaMedulloblastoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Paul G Schlegel, MD

    University Children's Hospital Pediatric Oncology Wuerzburg / Germany

    PRINCIPAL INVESTIGATOR
  • Matthias Eyrich, MD

    Pediatric Stem Cell Transplant Program

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

March 1, 2005

Study Completion

February 1, 2009

Last Updated

August 23, 2006

Record last verified: 2005-09

Locations