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

Completed

• Conditions: BK Virus Infection
• Interventions: Other: Symptom index questionnaire; Diagnostic Test: BK polyomavirus PCR; Other: quality of life questionnaires

• Registration Number: NCT03532971
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-05-10
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-22
• Study Start: 2018-07-30
• Primary Completion: 2020-09-14
• Study Completion: 2020-09-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
allogeneic hematopoietic-cell transplantation patients	Symptom index questionnaire	Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI
allogeneic hematopoietic-cell transplantation patients	quality of life questionnaires	Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI
allogeneic hematopoietic-cell transplantation patients	BK polyomavirus PCR	Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States