Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010

Viral Infections Clinical Trial

Official title:

Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111745
• Other study ID #: 999917079
• Secondary ID: 17-C-N079
• Status: Completed
• Start date: April 13, 2017
• Est. completion date: February 18, 2020

Study information

• Verified date: September 12, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: February 18, 2020
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 85 Years

Eligibility

• ELIGIBILITY CRITERIA:

Subjects will not be recruited for this study.

Related Conditions & MeSH terms

• Infections
• Viral Infections
• Virus Diseases

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kang 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. — View Citation

Reddehase 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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	1 year
Secondary	Evaluate the relationship between EBV and CMV in blood	Evaluate the relationship between EBV and CMV in blood	1 year
Secondary	evaluate relationship between viral infection and immunologic parameters	evaluate relationship between viral infection and immunologic parameters	1 year
Secondary	evaluate relationship between GVHD and viral infection incidence/burden	evaluate relationship between GVHD and viral infection incidence/burden	1 year
Secondary	determine overall survival and incidence of infection-related mortality	determine overall survival and incidence of infection-related mortality	1 year