Prospective Study of BK Virus Disease After Allogeneic Hematopoietic-cell Transplantation: Defining BK Disease's Natural History, Clinical Spectrum, Immunology, and Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-30

Study Completion Date

2020-09-14

Brief Summary

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This research study is evaluating the reactivation of BK virus in patients who have undergone allogeneic hematopoietic-cell transplantation.

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Detailed Description

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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.

Conditions

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BK Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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allogeneic hematopoietic-cell transplantation patients

Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI

Symptom index questionnaire

Intervention Type OTHER

A survey administered to identify the symptoms of the patient

BK polyomavirus PCR

Intervention Type DIAGNOSTIC_TEST

quantitative PCR testing

quality of life questionnaires

Intervention Type OTHER

Standard questionnaires validated for HCT recipients

Interventions

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Symptom index questionnaire

A survey administered to identify the symptoms of the patient

Intervention Type OTHER

BK polyomavirus PCR

quantitative PCR testing

Intervention Type DIAGNOSTIC_TEST

quality of life questionnaires

Standard questionnaires validated for HCT recipients

Intervention Type OTHER

Eligibility Criteria

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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