BK Virus InfectionNCT03532971
Prospective Study of BK Virus Disease After Allogeneic Hematopoietic-cell Transplantation: Defining BK Disease's Natural History, Clinical Spectrum, Immunology, and Outcomes
An observational study of BK Virus Infection, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating the reactivation of BK virus in patients who have undergone allogeneic hematopoietic-cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus Infection
- What is being tested?
- Symptom index questionnaire, BK polyomavirus PCR and quality of life questionnaires
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 14 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
This research study is evaluating the reactivation of BK virus in patients who have undergone allogeneic hematopoietic-cell transplantation.
Read the 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.
- Conditions
- BK Virus Infection
- Being tested
- Symptom index questionnaire, BK polyomavirus PCR, quality of life questionnaires
- Keywords
- BK virus, BK polyomavirus, hematopoietic-cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom index questionnaireOther
A survey administered to identify the symptoms of the patient
BK polyomavirus PCRDiagnostic test
quantitative PCR testing
quality of life questionnairesOther
Standard questionnaires validated for HCT recipients
| Study group | Role | What they receive |
|---|---|---|
| allogeneic hematopoietic-cell transplantation patients | Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI Receives: Other: Symptom index questionnaire; Diagnostic Test: BK polyomavirus PCR; Other: quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Analytically determine a BKV-specific cfDNA methylation pattern in the urine and plasma samples of affected patients
Measured: 2 years
Analytically determine BKV-specific antibody glycosylation patterns in plasma samples of patients who exhibit BKVR.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start30 Jul 2018
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK Virus InfectionStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerome Ritz, MD, Dana-Farber Cancer Institute
- Investigators
- Jerome Ritz, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532971
- Sponsor's protocol ID
- 17-664
- Status last verified
- May 2024
- First submitted
- 10 May 2018
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of BK Virus Disease After Allogeneic Hematopoietic-cell Transplantation: Defining BK Disease's Natural History, Clinical Spectrum, Immunology, and Outcomes
- ClinicalTrials.gov ID
- NCT03532971
- Acronym / sponsor ID
- 17-664
- Conditions
- BK Virus Infection
- Keywords
- BK virus, BK polyomavirus, hematopoietic-cell transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allogeneic hematopoietic-cell transplantation patients | – | Other: Symptom index questionnaire, Diagnostic Test: BK polyomavirus PCR, Other: quality of life questionnairesProspective HCT cohort of patients undergoing allogeneic HCT at DFCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom index questionnaireA survey administered to identify the symptoms of the patient | Other | allogeneic hematopoietic-cell transplantation patients |
| BK polyomavirus PCRquantitative PCR testing | Diagnostic test | allogeneic hematopoietic-cell transplantation patients |
| quality of life questionnairesStandard questionnaires validated for HCT recipients | Other | allogeneic hematopoietic-cell transplantation patients |
Primary outcome
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
2 secondary outcomes
Analytically determine a BKV-specific cfDNA methylation pattern in the urine and plasma samples of affected patients
Time frame: 2 years
Analytically determine BKV-specific antibody glycosylation patterns in plasma samples of patients who exhibit BKVR.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
Related trials for BK Virus Infection
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Kidney Diseases, Kidney Injury
Active, not recruitingPhase 2
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Transplantation Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome Ritz, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BK Virus Infection, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.