Abnormal HematopoiesisNCT02829216
Graft-versus-host Disease Associated Myelosuppression
An observational study of Abnormal Hematopoiesis and Allogenic Disease, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abnormal Hematopoiesis, Allogenic Disease, Graft vs Host Disease
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with AML/MDS receiving an allogeneic hematopoietic stem cell transplantation
Who may be able to join
- age >18
- acute myeloid leukemia
- myelodysplastic syndrome
- hematopoietic stem cell transplantation
Who cannot join
- not willing to take part
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden
Dresden, 01307
Malte von Bonin, MD
About this study
Official title: Functional Profiling of the Hematopoietic Stem Cell Niche in Graft Versus Host Disease Mediated Bone Marrow Insufficiency
The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.
- Keywords
- myelosuppression, mesenchymal stromal cells
- Medical subject headings
- Graft vs Host Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation
Measured: up to 1 year after allogeneic hematopoietic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal HematopoiesisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte von Bonin, MD, Principal investigator, Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829216
- Sponsor's protocol ID
- Bone marrow GvHD
- Status last verified
- Jul 2016
- First submitted
- 17 May 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Profiling of the Hematopoietic Stem Cell Niche in Graft Versus Host Disease Mediated Bone Marrow Insufficiency
- ClinicalTrials.gov ID
- NCT02829216
- Acronym / sponsor ID
- Bone marrow GvHD
- Keywords
- myelosuppression, mesenchymal stromal cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 12 Jul 2016 (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 objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with AML/MDS receiving an allogeneic hematopoietic stem cell transplantation
Key inclusion criteria (4 listed)
- age >18
- acute myeloid leukemia
- myelodysplastic syndrome
- hematopoietic stem cell transplantation
Key exclusion criteria (1 listed)
- not willing to take part
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
Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation
Time frame: up to 1 year after allogeneic hematopoietic stem cell transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Individual participant dataSharing planned: No
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.
Malte von Bonin, MD principal investigator
Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden
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 Abnormal Hematopoiesis and Allogenic Disease, run by Technische Universität Dresden 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 4 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 12 Jul 2016. 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 Malte von Bonin, MD (00493514586636, malte.bonin@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation (time frame: up to 1 year after allogeneic hematopoietic stem cell transplantation). It is what the study was designed to measure, not a finding.
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 12 Jul 2016.