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

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

Study Overview

• Status: Active, not recruiting
• Conditions: BK Virus Infection
• Intervention / Treatment: Other: Symptom index questionnaire; Diagnostic test: BK polyomavirus PCR; Other: quality of life questionnaires

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: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients who undergo allo-HCT will be eligible for the study, regardless of age, underlying disease, conditioning regimen, or GVHD prophylaxis regimen

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
allogeneic hematopoietic-cell transplantation patients; Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI	Other: Symptom index questionnaire; A survey administered to identify the symptoms of the patient; Diagnostic test: BK polyomavirus PCR; quantitative PCR testing; Other: quality of life questionnaires; 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	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	2 years
Analytically determine BKV-specific antibody glycosylation patterns in plasma samples of patients who exhibit BKVR.	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jerome Ritz, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Actual): September 14, 2020
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: BK virus; BK polyomavirus; hematopoietic-cell transplantation
• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: 17-664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No