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NCT03532971 Clinical Trial

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

BK Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03532971
Other study ID # 17-664
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 30, 2018
Est. completion date September 14, 2020

Study information
Verified date May 2024
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 14, 2020
Est. primary completion date September 14, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Analytically determine a BKV-specific cfDNA methylation pattern in the urine and plasma samples of affected patients 2 years
Secondary Analytically determine BKV-specific antibody glycosylation patterns in plasma samples of patients who exhibit BKVR. 2 years
See also
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Active, not recruiting NCT05026021 - Prediction of BKvirus Nephropathy Risk by the NEPHROVIR Method in Kidney Transplant Patients With BKvirus Viremia
Recruiting NCT05511779 - Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation Phase 2
Recruiting NCT05183490 - R-MVST Cells for Treatment of Viral Infections Phase 1
Active, not recruiting NCT00684372 - BK Viremia After Renal Transplantation N/A
Recruiting NCT06219616 - Prediction of BK Virus Reactivation in Kidney Transplant Recipient N/A
Not yet recruiting NCT05264259 - New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
Terminated NCT05305040 - Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Phase 2/Phase 3
Completed NCT04605484 - Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia Phase 2
Terminated NCT04390113 - Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC) Phase 3
Withdrawn NCT02313844 - Most Closely Human Leukocyte Antigen (HLA)-Matched BK Virus-specific T Lymphocytes (Viralym-B) Phase 1
Recruiting NCT02479698 - Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus Phase 2
Recruiting NCT05101213 - Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients Phase 1
Completed NCT01789203 - Ciprofloxacin for Prevention of BK Infection Phase 4
Completed NCT04693637 - Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Phase 2/Phase 3
Recruiting NCT05618275 - Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS
Recruiting NCT04542733 - The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient N/A
Recruiting NCT05042076 - BK With VST for Kidney Transplant Patients Phase 1
Completed NCT04294472 - A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients Phase 2