NCT02346617

Brief Summary

To evaluate the safety and efficacy for treatment of persistent CMV infection in hematopoietic cell transplant (HCT) recipients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 13, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
6.9 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

January 13, 2015

Last Update Submit

March 18, 2020

Conditions

Cytomegalovirus Infections

Keywords

CMVT cell therapy

Outcome Measures

Primary Outcomes (1)

  • Level of enriched IFN-Υ+ T-cells upon pp65 stimulation

    2 weeks

Secondary Outcomes (1)

  • Treatment efficacy of CMV infection, defined as reduction of CMV viremia, ex vivo enrichment of CMV antigen (pp65) -specific T cells in peripheral blood.

    2 weeks

Study Arms (1)

allogeneic HSCT

EXPERIMENTAL

The present study will investigate in a single-center (Samsung Medical Center), open-label, single arm by direct infusions of donor-derived CMV-spefic IFN-γ positive T-cells for the treatment of refractory CMV infection in allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Biological: IFN-γ positive selected T-cells

Interventions

IFN-γ positive selected T-cellsBIOLOGICAL

No intervention

allogeneic HSCT

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Less than 66 years old Allogeneic HCT recipients who received stem cells from related CMV positive serology donors
  • AND recipients have persistent CMV infection more than 2 weeks on antiviral treatment

You may not qualify if:

  • HCT recipients with severe graft versus host disease, grade 3 or more
  • OR organ dysfunction (brain, heart, lung, liver, and kidney): altered mentality, extracorporeal membrane oxygenation, mechanical ventilator, increased liver enzymes 5 times above upper normal values, bilirubin level \>3 mg/dL, CrCl \< 30 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-Gu, 135-710, South Korea

Location

Related Publications (10)

  • Kim YJ, Boeckh M, Cook L, Stempel H, Jerome KR, Boucek R Jr, Burroughs L, Englund JA. Cytomegalovirus infection and ganciclovir resistance caused by UL97 mutations in pediatric transplant recipients. Transpl Infect Dis. 2012 Dec;14(6):611-7. doi: 10.1111/j.1399-3062.2012.00760.x.

    PMID: 23198963BACKGROUND

  • Feuchtinger T, Opherk K, Bethge WA, Topp MS, Schuster FR, Weissinger EM, Mohty M, Or R, Maschan M, Schumm M, Hamprecht K, Handgretinger R, Lang P, Einsele H. Adoptive transfer of pp65-specific T cells for the treatment of chemorefractory cytomegalovirus disease or reactivation after haploidentical and matched unrelated stem cell transplantation. Blood. 2010 Nov 18;116(20):4360-7. doi: 10.1182/blood-2010-01-262089. Epub 2010 Jul 12.

    PMID: 20625005BACKGROUND

  • Peggs KS, Thomson K, Samuel E, Dyer G, Armoogum J, Chakraverty R, Pang K, Mackinnon S, Lowdell MW. Directly selected cytomegalovirus-reactive donor T cells confer rapid and safe systemic reconstitution of virus-specific immunity following stem cell transplantation. Clin Infect Dis. 2011 Jan 1;52(1):49-57. doi: 10.1093/cid/ciq042.

    PMID: 21148519BACKGROUND

  • Peggs KS, Verfuerth S, Pizzey A, Chow SL, Thomson K, Mackinnon S. Cytomegalovirus-specific T cell immunotherapy promotes restoration of durable functional antiviral immunity following allogeneic stem cell transplantation. Clin Infect Dis. 2009 Dec 15;49(12):1851-60. doi: 10.1086/648422.

    PMID: 19911966BACKGROUND

  • Yi ES, Kim YJ. Cytomegalovirus infection according to cell source after hematopoietic cell transplantation in pediatric patients. Yonsei Med J. 2012 Mar;53(2):393-400. doi: 10.3349/ymj.2012.53.2.393.

    PMID: 22318829BACKGROUND

  • Tomblyn M, Chiller T, Einsele H, Gress R, Sepkowitz K, Storek J, Wingard JR, Young JA, Boeckh MJ; Center for International Blood and Marrow Research; National Marrow Donor program; European Blood and MarrowTransplant Group; American Society of Blood and Marrow Transplantation; Canadian Blood and Marrow Transplant Group; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America; Association of Medical Microbiology and Infectious Disease Canada; Centers for Disease Control and Prevention. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow Transplant. 2009 Oct;15(10):1143-238. doi: 10.1016/j.bbmt.2009.06.019. No abstract available.

    PMID: 19747629BACKGROUND

  • Boeckh M, Ljungman P. How we treat cytomegalovirus in hematopoietic cell transplant recipients. Blood. 2009 Jun 4;113(23):5711-9. doi: 10.1182/blood-2008-10-143560. Epub 2009 Mar 18.

    PMID: 19299333BACKGROUND

  • Vivier E, Ugolini S. Natural killer cells: from basic research to treatments. Front Immunol. 2011 Jun 3;2:18. doi: 10.3389/fimmu.2011.00018. eCollection 2011. No abstract available.

    PMID: 22566808BACKGROUND

  • Hadaya K, Avila Y, Valloton L, de Rham C, Bandelier C, Ferrari-Lacraz S, Pascual M, Pantaleo G, Martin PY, Buhler L, Villard J. Natural killer cell receptor--repertoire and functions after induction therapy by polyclonal rabbit anti-thymocyte globulin in unsensitized kidney transplant recipients. Clin Immunol. 2010 Nov;137(2):250-60. doi: 10.1016/j.clim.2010.07.004. Epub 2010 Aug 17.

    PMID: 20719569BACKGROUND

  • Vacher-Coponat H, Brunet C, Moal V, Loundou A, Bonnet E, Lyonnet L, Ravet S, Sampol-Manos E, Sampol J, Berland Y, George FD, Paul P. Tacrolimus/mycophenolate mofetil improved natural killer lymphocyte reconstitution one year after kidney transplant by reference to cyclosporine/azathioprine. Transplantation. 2006 Aug 27;82(4):558-66. doi: 10.1097/01.tp.0000229390.01369.4a.

    PMID: 16926601BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Yae-Jean Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 27, 2015

Study Start

January 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

KR(1)