Graft-versus-host Disease Associated Myelosuppression | NCT02829216

Studies
Graft-versus-host Disease Associated Myelosuppression

NCT02829216

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Jul 12, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Abnormal Hematopoiesis
Allogenic Disease
Graft vs Host Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Apr 2017Estimated

Completion Date

Not provided

First Submitted Date

May 17, 2016

First Submission Date that Met QC Criteria

Jul 7, 2016

First Posted Date

Jul 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2016

Last Update Posted Date

Jul 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation		up to 1 year after allogeneic hematopoietic stem cell transplantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >18
acute myeloid leukemia
myelodysplastic syndrome
hematopoietic stem cell transplantation

Exclusion Criteria:

not willing to take part

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with AML/MDS receiving an allogeneic hematopoietic stem cell transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Malte von Bonin, MD	Contact	00493514586636		malte.bonin@uniklinikum-dresden.de

Overall Officials

Name	Affiliation	Role
Malte von Bonin, MD	Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden	Recruiting	Dresden		01307	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006086	Graft vs Host Disease

Ancestor Terms

ID	Term
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided