Clinical trial NCT02090803: Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells
Official title: Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells , Prospective, Open, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Diseases
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patient

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.


Eligibility criteria: 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

Primary outcomes:
measure: HHV-6 biological reactivation
timeFrame: 40 days
Secondary outcomes:
measure: Aplasia output or engraftment
timeFrame: 40 days
measure: Reconstitution of hematopoiesis
timeFrame: 40 days
measure: Disease HHV-6
timeFrame: 40 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lyon
country: France
facility: HCL
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne - laboratoire de virologie
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Marie Balsat, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Ljungman P. Immune reconstitution and viral infections after stem cell transplantation. Bone Marrow Transplant. 1998 Apr;21 Suppl 2:S72-4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Ogata M. Human herpesvirus 6 in hematological malignancies. J Clin Exp Hematop. 2009 Nov;49(2):57-67. doi: 10.3960/jslrt.49.57.