Viral InfectionsNCT03111745
Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010
An observational study of Viral Infections, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Some blood and immune disorders can be helped with HSCT. This is allogeneic hematopoietic stem cell transplantation. The person who gets the stem cells has their immune system suppressed. This is done to help prevent their body from rejecting the transplant. Read more about this study
- Who is it for?
- Ages 4 to 85 years
- Conditions the study is for
- Viral Infections
- How many people
- 730 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 18 Feb 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 4 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This protocol is a retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) at the NIH Clinical Center
- ELIGIBILITY CRITERIA:
Subjects will not be recruited for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Background:
Some blood and immune disorders can be helped with HSCT. This is allogeneic hematopoietic stem cell transplantation. The person who gets the stem cells has their immune system suppressed. This is done to help prevent their body from rejecting the transplant. During this time, the person is at a high risk to get viral infections. Researchers want to study the records of people who had transplants a few years ago. They want to look at how often certain viral complications happened.
Read more
Objective:
To study how often certain viral complications occurred after HSCT and what risks factors were involved.
Eligibility:
Records will be reviewed. No participants will be contacted.
Design:
Researchers will review medical records from the NIH Clinical Center.
The records will be from people who had HSCT between 2010 and 2015 when they were between 4 and 85 years old. They already gave consent for their data to be studied.
Data collected will include:
Vital statistics like age and sex
Viral status of the recipient and donor
Reason for transplant
Transplant details
How the immune system recovered after transplant
If the recipient got graft versus host disease
Any infections
Overall survival
Read the detailed description
This protocol is a retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) at the NIH Clinical Center. If this proposal is approved, BTRIS will identify and populate the patients in these protocols, and BTRIS identified reports will be used going forward.
BTRIS identified reports will be used to review patient progress notes, all aspects of the transplant platform, as well as viral titers over the course of each patient s follow-up, supplemented by review of paper or CRIS electronic medical records as needed.
The study will involve review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled in NIH protocols between 2010 and December 1, 2020. BTRIS policy requires approval from Principal Investigators on certain protocols. These Principal Investigators have been contacted via email for permission to conduct this study and have verified that none of the original protocols or informed consent documents precludes such a review of clinical data.
- Conditions
- Viral Infections
- Keywords
- Reactivation or Proliferation of Latent Viral Infections., Viral Infection, Lymphoproliferation, Natural History
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.
Incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.
Measured: 1 year
Secondary outcomes (5)
incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease
incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease
Measured: 1 year
Evaluate the relationship between EBV and CMV in blood
Evaluate the relationship between EBV and CMV in blood
Measured: 1 year
evaluate relationship between viral infection and immunologic parameters
evaluate relationship between viral infection and immunologic parameters
Measured: 1 year
evaluate relationship between GVHD and viral infection incidence/burden
evaluate relationship between GVHD and viral infection incidence/burden
Measured: 1 year
determine overall survival and incidence of infection-related mortality
determine overall survival and incidence of infection-related mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start13 Apr 2017
- Primary completion29 Dec 2018
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Viral InfectionsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Retrospective
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dimana Dimitrova, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111745
- Sponsor's protocol ID
- 999917079
- Other IDs
- 17-C-N079
- Status last verified
- 6 May 2026
- First submitted
- 12 Apr 2017
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Tischer J, Engel N, Fritsch S, Prevalsek D, Hubmann M, Schulz C, Zoellner AK, Bucklein V, Reibke R, Mumm F, Rieger CT, Hill W, Ledderose G, Stemmler HJ, Kohnke T, Jager G, Kolb HJ, Schmid C, Moosmann A, Hausmann A. Virus infection in HLA-haploidentical hematopoietic stem cell transplantation: incidence in the context of immune recovery in two different transplantation settings. Ann Hematol. 2015 Oct;94(10):1677-88. doi: 10.1007/s00277-015-2423-y. Epub 2015 Jun 10.
PubMed 26055139Kang E, Gennery A. Hematopoietic stem cell transplantation for primary immunodeficiencies. Hematol Oncol Clin North Am. 2014 Dec;28(6):1157-70. doi: 10.1016/j.hoc.2014.08.006. Epub 2014 Sep 16.
PubMed 25459185Reddehase MJ. Mutual Interference between Cytomegalovirus and Reconstitution of Protective Immunity after Hematopoietic Cell Transplantation. Front Immunol. 2016 Aug 4;7:294. doi: 10.3389/fimmu.2016.00294. eCollection 2016.
PubMed 27540380
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010
- ClinicalTrials.gov ID
- NCT03111745
- Acronym / sponsor ID
- 999917079
- Conditions
- Viral Infections
- Keywords
- Reactivation or Proliferation of Latent Viral Infections., Viral Infection, Lymphoproliferation, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 29 Dec 2018 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 13 Apr 2017 (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.
Background:
Some blood and immune disorders can be helped with HSCT. This is allogeneic hematopoietic stem cell transplantation. The person who gets the stem cells has their immune system suppressed. This is done to help prevent their body from rejecting the transplant. During this time, the person is at a high risk to get viral infections. Researchers want to study the records of people who had transplants a few years ago. They want to look at how often certain viral complications happened.
Objective:
To study how often certain viral complications occurred after HSCT and what risks factors were involved.
Eligibility:
Records will be reviewed. No participants will be contacted.
Design:
Researchers will review medical records from the NIH Clinical Center.
The records will be from people who had HSCT between 2010 and 2015 when they were between 4 and 85 years old. They already gave consent for their data to be studied.
Data collected will include:
Vital statistics like age and sex
Viral status of the recipient and donor
Reason for transplant
Transplant details
How the immune system recovered after transplant
If the recipient got graft versus host disease
Any infections
Overall survival
Detailed description
This protocol is a retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) at the NIH Clinical Center. If this proposal is approved, BTRIS will identify and populate the patients in these protocols, and BTRIS identified reports will be used going forward.
BTRIS identified reports will be used to review patient progress notes, all aspects of the transplant platform, as well as viral titers over the course of each patient s follow-up, supplemented by review of paper or CRIS electronic medical records as needed.
The study will involve review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled in NIH protocols between 2010 and December 1, 2020. BTRIS policy requires approval from Principal Investigators on certain protocols. These Principal Investigators have been contacted via email for permission to conduct this study and have verified that none of the original protocols or informed consent documents precludes such a review of clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) |
Who may qualify
- Ages
- 4 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This protocol is a retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) at the NIH Clinical Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.
Time frame: 1 year
Incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution.
5 secondary outcomes
incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease
Time frame: 1 year
Evaluate the relationship between EBV and CMV in blood
Time frame: 1 year
evaluate relationship between viral infection and immunologic parameters
Time frame: 1 year
evaluate relationship between GVHD and viral infection incidence/burden
Time frame: 1 year
determine overall survival and incidence of infection-related mortality
Time frame: 1 year
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 8 Oct 2026.
- Background: PubMed 26055139Tischer J, Engel N, Fritsch S, Prevalsek D, Hubmann M, Schulz C, Zoellner AK, Bucklein V, Reibke R, Mumm F, Rieger CT, Hill W, Ledderose G, Stemmler HJ, Kohnke T, Jager G, Kolb HJ, Schmid C, Moosmann A, Hausmann A. Virus infection in HLA-haploidentical hematopoietic stem cell transplantation: incidence in the context of immune recovery in two different transplantation settings. Ann Hematol. 2015 Oct;94(10):1677-88. doi: 10.1007/s00277-015-2423-y. Epub 2015 Jun 10.
- Background: PubMed 25459185Kang E, Gennery A. Hematopoietic stem cell transplantation for primary immunodeficiencies. Hematol Oncol Clin North Am. 2014 Dec;28(6):1157-70. doi: 10.1016/j.hoc.2014.08.006. Epub 2014 Sep 16.
- Background: PubMed 27540380Reddehase MJ. Mutual Interference between Cytomegalovirus and Reconstitution of Protective Immunity after Hematopoietic Cell Transplantation. Front Immunol. 2016 Aug 4;7:294. doi: 10.3389/fimmu.2016.00294. eCollection 2016.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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.
Dimana Dimitrova, M.D. principal investigator
National Cancer Institute (NCI)
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 Viral Infections, run by National Cancer Institute (NCI) 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?
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 8 Oct 2026. 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?
To determine the incidence and risk factors for various viral complications by HSCT platform and its relation to immune reconstitution. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03111745, which also lists 3 linked publications.
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 8 Oct 2026.