Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells

NCT ID: NCT02090803

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to assess the human herpes virus reactivation 6 post autologous stem cells in 196 patients. The aim of our study was to describe the incidence of reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic role in this target population.

Detailed Description

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Conditions

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Hematologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Graft of autologous hematopoietic stem cells

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* all patients hospitalized in the Hematology Clinic of Saint-Etienne and Clermont-Ferrand and receiving autologous hematopoietic stem cells, according to the decision of the Consultative Meeting Multidisciplinary service;
* Autologous recipients are included irrespective of causal hemopathy (myeloma, lymphoma, acute leukemia, mainly).

Exclusion Criteria

* The non-consenting patients or unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de la Loire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Balsat, MD

Role: STUDY_CHAIR

Institut de Cancérologie Lucien Neuwirth

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

HCL

Lyon, , France

Site Status

CHU Saint-Etienne - laboratoire de virologie

Saint-Etienne, , France

Site Status

Countries

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France

References

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De Bolle L, Naesens L, De Clercq E. Update on human herpesvirus 6 biology, clinical features, and therapy. Clin Microbiol Rev. 2005 Jan;18(1):217-45. doi: 10.1128/CMR.18.1.217-245.2005.

Reference Type BACKGROUND
PMID: 15653828 (View on PubMed)

Boutolleau D, Duros C, Bonnafous P, Caiola D, Karras A, Castro ND, Ouachee M, Narcy P, Gueudin M, Agut H, Gautheret-Dejean A. Identification of human herpesvirus 6 variants A and B by primer-specific real-time PCR may help to revisit their respective role in pathology. J Clin Virol. 2006 Mar;35(3):257-63. doi: 10.1016/j.jcv.2005.08.002. Epub 2005 Sep 23.

Reference Type BACKGROUND
PMID: 16183328 (View on PubMed)

Yamanishi K, Okuno T, Shiraki K, Takahashi M, Kondo T, Asano Y, Kurata T. Identification of human herpesvirus-6 as a causal agent for exanthem subitum. Lancet. 1988 May 14;1(8594):1065-7. doi: 10.1016/s0140-6736(88)91893-4.

Reference Type BACKGROUND
PMID: 2896909 (View on PubMed)

Santoro F, Kennedy PE, Locatelli G, Malnati MS, Berger EA, Lusso P. CD46 is a cellular receptor for human herpesvirus 6. Cell. 1999 Dec 23;99(7):817-27. doi: 10.1016/s0092-8674(00)81678-5.

Reference Type BACKGROUND
PMID: 10619434 (View on PubMed)

Agut H. Deciphering the clinical impact of acute human herpesvirus 6 (HHV-6) infections. J Clin Virol. 2011 Nov;52(3):164-71. doi: 10.1016/j.jcv.2011.06.008. Epub 2011 Jul 22.

Reference Type BACKGROUND
PMID: 21782505 (View on PubMed)

Ljungman P, Wang FZ, Clark DA, Emery VC, Remberger M, Ringden O, Linde A. High levels of human herpesvirus 6 DNA in peripheral blood leucocytes are correlated to platelet engraftment and disease in allogeneic stem cell transplant patients. Br J Haematol. 2000 Dec;111(3):774-81.

Reference Type BACKGROUND
PMID: 11122137 (View on PubMed)

Ljungman P. Immune reconstitution and viral infections after stem cell transplantation. Bone Marrow Transplant. 1998 Apr;21 Suppl 2:S72-4.

Reference Type BACKGROUND
PMID: 9630332 (View on PubMed)

Agut H. [Acute human herpesvirus 6 (HHV-6) infections: when and how to treat?]. Pathol Biol (Paris). 2011 Apr;59(2):108-12. doi: 10.1016/j.patbio.2010.07.015. Epub 2010 Sep 15. French.

Reference Type BACKGROUND
PMID: 20832191 (View on PubMed)

Kamble RT, Clark DA, Leong HN, Heslop HE, Brenner MK, Carrum G. Transmission of integrated human herpesvirus-6 in allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2007 Sep;40(6):563-6. doi: 10.1038/sj.bmt.1705780. Epub 2007 Jul 16.

Reference Type BACKGROUND
PMID: 17637686 (View on PubMed)

Lee SO, Brown RA, Razonable RR. Clinical significance of pretransplant chromosomally integrated human herpesvirus-6 in liver transplant recipients. Transplantation. 2011 Jul 27;92(2):224-9. doi: 10.1097/TP.0b013e318222444a.

Reference Type BACKGROUND
PMID: 21629177 (View on PubMed)

Moreau P, Facon T, Attal M, Hulin C, Michallet M, Maloisel F, Sotto JJ, Guilhot F, Marit G, Doyen C, Jaubert J, Fuzibet JG, Francois S, Benboubker L, Monconduit M, Voillat L, Macro M, Berthou C, Dorvaux V, Pignon B, Rio B, Matthes T, Casassus P, Caillot D, Najman N, Grosbois B, Bataille R, Harousseau JL; Intergroupe Francophone du Myelome. Comparison of 200 mg/m(2) melphalan and 8 Gy total body irradiation plus 140 mg/m(2) melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the Intergroupe Francophone du Myelome 9502 randomized trial. Blood. 2002 Feb 1;99(3):731-5. doi: 10.1182/blood.v99.3.731.

Reference Type BACKGROUND
PMID: 11806971 (View on PubMed)

Leong HN, Tuke PW, Tedder RS, Khanom AB, Eglin RP, Atkinson CE, Ward KN, Griffiths PD, Clark DA. The prevalence of chromosomally integrated human herpesvirus 6 genomes in the blood of UK blood donors. J Med Virol. 2007 Jan;79(1):45-51. doi: 10.1002/jmv.20760.

Reference Type BACKGROUND
PMID: 17133548 (View on PubMed)

Ogata M. Human herpesvirus 6 in hematological malignancies. J Clin Exp Hematop. 2009 Nov;49(2):57-67. doi: 10.3960/jslrt.49.57.

Reference Type BACKGROUND
PMID: 19907110 (View on PubMed)

Other Identifiers

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2012-A000243-40

Identifier Type: OTHER

Identifier Source: secondary_id

2012-01

Identifier Type: -

Identifier Source: org_study_id

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