LeukemiaNCT00231712
Immuno 1: Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Stem Cell Transplant
An observational study of Leukemia and Medulloblastoma, run by Julius-Maximilians University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Leukemia, Medulloblastoma
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No written consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Children's Hospital Pedaitric Oncology
Würzburg, D97080
Beate Winkler, MD, 49 - 931 - 201 - 27831, winkler_b@klinik.uni.wuerzburg.de
Beate Winkler, MD
About this study
Official title: Prospective Analysis of the Patterns of Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Autologous/Allogeneic Stem Cell Transplant
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.
Read the 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
- Conditions
- Leukemia, Medulloblastoma
- Keywords
- prospective analysis of immune function,, spectratype, immunoscope, TREC analysis, solid tumor
- Medical subject headings
- Leukemia, Medulloblastoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startMar 2005
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Julius-Maximilians University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg
- Investigators
- Paul G Schlegel, MD, Principal investigator, University Children's Hospital Pediatric Oncology Wuerzburg / GermanyMatthias Eyrich, MD, Study director, Pediatric Stem Cell Transplant Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231712
- Sponsor's protocol ID
- 133/04
- Status last verified
- Sep 2005
- First submitted
- 30 Sep 2005
- Last updated
- 23 Aug 2006
- Results posted
- No
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. doi: 10.1016/j.bbmt.2004.12.001.
PubMed 15744238Eyrich 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.
PubMed 12900774Eyrich 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.
PubMed 12176918
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Patterns of Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Autologous/Allogeneic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00231712
- Acronym / sponsor ID
- 133/04
- Conditions
- Leukemia, Medulloblastoma
- Keywords
- prospective analysis of immune function,, spectratype, immunoscope, TREC analysis, solid tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Julius-Maximilians UniversityUniversity, hospital or other
- Collaborators
- University of Wuerzburg
- Study start
- Mar 2005
- Study completion
- Feb 2009
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- No written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2006.
- Background: PubMed 15744238Eyrich 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.
- Background: PubMed 12900774Eyrich 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.
- Background: PubMed 12176918Eyrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul G Schlegel, MD principal investigator
University Children's Hospital Pediatric Oncology Wuerzburg / Germany
Matthias Eyrich, MD study director
Pediatric Stem Cell Transplant Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Medulloblastoma, run by Julius-Maximilians University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul G Schlegel, MD (+49 - 931 - 201 - 27831, schlegel@mail.uni-wuerzburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00231712, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2006.