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

NCT03111745 | Completed

• 2 other identifiers: 99991707917-C-N079
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Viral Infections

Keywords

Reactivation or Proliferation of Latent Viral Infections.; Viral Infection; Lymphoproliferation; Natural History

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• incidence of late CMV, EBV, BK cystitis, adenovirus, HHV6 encephalitis, JC virus, and CNS disease

  1 year

• Evaluate the relationship between EBV and CMV in blood

  1 year

• evaluate relationship between viral infection and immunologic parameters

  1 year

• evaluate relationship between GVHD and viral infection incidence/burden

  1 year

• determine overall survival and incidence of infection-related mortality

  1 year

Study Arms (1)

1

Retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT)

Eligibility Criteria

• Age: 4 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 26055139 BACKGROUND

• 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.

  PMID: 25459185 BACKGROUND

• 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.

  PMID: 27540380 BACKGROUND

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Dimana Dimitrova, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 13, 2017
• Study Start: April 13, 2017
• Primary Completion: December 29, 2018
• Study Completion: February 18, 2020
• Last Updated: May 7, 2026

Record last verified: 2025-08-27

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)