Hematopoietic Stem Cell TransplantationNCT00179049
Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant
An observational study of Hematopoietic Stem Cell Transplantation and Graft vs Host Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Graft vs Host Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Apr 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions
Who may be able to join
- Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions
Who cannot join
- Patients < 18 or > 70 years old undergoing either autologous transplant or allogeneic transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5505
About this study
Official title: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant (HSCT)
The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease.
Read the detailed description
The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease (GVHD) by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Their understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.
- Keywords
- T-Lymphocyte Subsets
- Medical subject headings
- Graft vs Host Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2003
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Adetola A Kassim, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179049
- Sponsor's protocol ID
- BMT 030261
- Status last verified
- Dec 2008
- First submitted
- 13 Sep 2005
- Last updated
- 15 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant (HSCT)
- ClinicalTrials.gov ID
- NCT00179049
- Acronym / sponsor ID
- BMT 030261
- Keywords
- T-Lymphocyte Subsets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Sep 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 investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease.
Detailed description
The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease (GVHD) by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Their understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions
Key inclusion criteria (1 listed)
- Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions
Key exclusion criteria (1 listed)
- Patients < 18 or > 70 years old undergoing either autologous transplant or allogeneic transplant
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2008.
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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.
Adetola A Kassim, M.D. principal investigator
Vanderbilt University
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 Hematopoietic Stem Cell Transplantation and Graft vs Host Disease, run by Vanderbilt University at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 15 Dec 2008. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 15 Dec 2008.