- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03532971
Prospective Study of BK Virus Disease After Allogeneic Hematopoietic-cell Transplantation: Defining BK Disease's Natural History, Clinical Spectrum, Immunology, and Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Every year, more than 25,000 patients worldwide receive lifesaving bone marrow transplantations with hematopoietic-cells from another person. It is estimated that over 75% of these patients will develop an infectious complication, of which approximately one third can be life-threatening. A significant proportion of these infections are caused by opportunistic viruses, such as BK virus.
This virus establishes latent infection in most individuals, but does not normally cause disease. It can reactivate after hematopoietic-cell transplantation and represents the second most common viral infection in this patient population. BK virus is associated with kidney failure and a decreased chance of survival after hematopoietic-cell transplantation. There are no effective antiviral treatments for this disease.
Despite being the second most common cause of clinical disease hematopoietic-cell transplantation, very little is known about this virus. To address this knowledge gap, the investigators aim to study patients with confirmed BK virus disease post allogeneic hematopoietic-cell transplantation.
As part of this study, regular urine and blood tests will be done to understand how the virus behaves over time and which organs it affects. Blood and urine samples will also be obtained to study how the immune system rebuilds itself after hematopoietic-cell transplantation. Finally, an ultrasound of the kidneys and the bladder will be done to evaluate for any presence of disease in these organs.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult ≥18 years old
- All adult patients who undergo allo-HCT will be eligible for the study, regardless of age, underlying disease, conditioning regimen, or GVHD prophylaxis regimen
Exclusion Criteria:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
allogeneic hematopoietic-cell transplantation patients
Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI
|
A survey administered to identify the symptoms of the patient
quantitative PCR testing
Standard questionnaires validated for HCT recipients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The mean total number of cytokine producing BKV-specific NK and T-cells at the time of BKVD in affected patients, as compared with unaffected patients
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analytically determine a BKV-specific cfDNA methylation pattern in the urine and plasma samples of affected patients
Time Frame: 2 years
|
2 years
|
Analytically determine BKV-specific antibody glycosylation patterns in plasma samples of patients who exhibit BKVR.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jerome Ritz, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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