NCT02090803

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 14, 2017

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

March 17, 2014

Last Update Submit

September 13, 2017

Conditions

Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

  • HHV-6 biological reactivation

    HHV-6 biological reactivation (blood viral load) is defined by a detectable viral load HHV-6 and\> 450 copies / mL on two occasions one week apart.

    40 days

Secondary Outcomes (3)

  • Aplasia output or engraftment

    40 days

  • Reconstitution of hematopoiesis

    40 days

  • Disease HHV-6

    40 days

Study Arms (1)

Graft of autologous hematopoietic stem cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive patient

You may qualify if:

  • 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).

You may not qualify if:

  • The non-consenting patients or unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

HCL

Lyon, France

Location

CHU Saint-Etienne - laboratoire de virologie

Saint-Etienne, 42000, France

Location

Related Publications (13)

  • 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.

    PMID: 15653828BACKGROUND

  • 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.

    PMID: 16183328BACKGROUND

  • 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.

    PMID: 2896909BACKGROUND

  • 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.

    PMID: 10619434BACKGROUND

  • 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.

    PMID: 21782505BACKGROUND

  • 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.

    PMID: 11122137BACKGROUND

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

    PMID: 9630332BACKGROUND

  • 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.

    PMID: 20832191BACKGROUND

  • 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.

    PMID: 17637686BACKGROUND

  • 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.

    PMID: 21629177BACKGROUND

  • 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.

    PMID: 11806971BACKGROUND

  • 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.

    PMID: 17133548BACKGROUND

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

    PMID: 19907110BACKGROUND

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

  • Marie Balsat, MD

    Institut de Cancérologie Lucien Neuwirth

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 18, 2014

Study Start

August 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 14, 2017

Record last verified: 2014-03

Locations

FR(3)