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OpenTrials
Completed

NCT Number: NCT03532971

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symptom index questionnaire

Other

A survey administered to identify the symptoms of the patient

BK polyomavirus PCR

Diagnostic Test

quantitative PCR testing

Quality of life questionnaires

Other

Standard questionnaires validated for HCT recipients

Primary outcomes

  1. 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

Secondary outcomes

  1. Analytically determine a BKV-specific cfDNA methylation pattern in the urine and plasma samples of affected patients

    Time frame: 2 years

  2. Analytically determine BKV-specific antibody glycosylation patterns in plasma samples of patients who exhibit BKVR.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 22, 2018
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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