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

NCT ID: NCT00231712

Last Updated: 2006-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia Medulloblastoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

prospective analysis of immune function, spectratype immunoscope TREC analysis solid tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wuerzburg

OTHER

Sponsor Role collaborator

Julius-Maximilians University

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul G Schlegel, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Pediatric Oncology Wuerzburg / Germany

Matthias Eyrich, MD

Role: STUDY_DIRECTOR

Pediatric Stem Cell Transplant Program

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Children's Hospital Pedaitric Oncology

Würzburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paul G Schlegel, MD

Role: CONTACT

Phone: +49 - 931 - 201 - 27831

Email: [email protected]

Beate Winkler, MD

Role: CONTACT

Phone: 49 - 931 - 201 - 27831

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Beate Winkler, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15744238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12900774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12176918 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

133/04

Identifier Type: -

Identifier Source: org_study_id