NCT02456610

Brief Summary

Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) cause significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral drugs given either prophylactically or as early therapy for patients with detectable viral loads appear to be an effective strategy for reducing viral infections. However, long-term treatment with these drugs is associated with significant toxicity, expense and the appearance of drug resistant virus isolates ultimately resulting in treatment failure. CMV and EBV specific T cells infusion to immunocompromised patients following HSCT is able to induce a successful anti-viral response. The primary purpose of this study is to determine the safety and efficacy of the infusion of CMV and EBV specific cytotoxic T cells (CTLs) for patients with CMV and EBV reactivation or infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

May 21, 2015

Last Update Submit

February 18, 2016

Conditions

Viral Infection

Outcome Measures

Primary Outcomes (2)

  • Toxicity of adoptive transfer of CMV/EBV specific CTLs(The increase of temperature by 1℃ and/or the appearance of rash within 24h after infusion)

    Assessment of acute transfusion toxicity within 24 hours after adoptive CTLs transfer

    24 hours

  • Assessment of viral load response to the CTL infusion assessed by CMV/EBV specific PCR of peripheral blood

    Assess the effect of the CTL infusion on viral load

    3 months

Secondary Outcomes (3)

  • The incidence of Ⅱ~Ⅳ°aGVHD within 30 days after the last dose of CTL infusion

    3 months

  • Reconstitution of antiviral immunity monitored by flow cytometry

    6 months

  • Number of patients with chronic GVHD

    6 months

Study Arms (1)

Infusion of CMV/EBV specific CTLs

EXPERIMENTAL

Repetitive CTLs infusion to treat CMV/EBV activation and infection

Biological: CMV/EBV specific CTLs

Interventions

CMV/EBV specific CTLsBIOLOGICAL

Patients will receive approximately 1x10e6 CTLs/kg as a single infusion via IV injection and may receive 1 to 8 additional infusions at intervals of one week.

Infusion of CMV/EBV specific CTLs

Eligibility Criteria

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

You may qualify if:

  • Patients with any type of allogeneic HSCT
  • CMV, adenovirus or EBV activation or infection which is defined as below. EBV/CMV reactivation is defined as CMV/EBV DNA levels \> 1000 IU/ml for a single test or \> 500 IU/ml for two consecutive tests. EBV/CMV related disease were defined as the demonstration of CMV/EBV biopsy specimen or clinical diagnosis through symptoms, signs or radiography.
  • Written informed consent and/or signed assent line from patient, parent or guardian
  • Positive CMV or EBV serology of the donor
  • Absence of severe renal disease (Creatinine \> 3x upper limit normal)
  • Absence of severe hepatic disease (Bilirubin \> 3x upper limit normal, AST \> 3x upper limit normal)
  • Life expectancy \> 30 days

You may not qualify if:

  • Active acute GVHD grades II-IV
  • Received donor lymphocytes infusion(DLI) within 30 days
  • Received ATG or other immunosuppressive monoclonal antibodies within 30 days
  • Uncontrolled acute infections
  • Active and relapse of malignancy
  • Received steroids treatment more than 0.5 mg/kg/day prednisone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Chen Hu, M.D., Ph.D.

    Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Bin, M.D., Ph.D.

CONTACT

+86-010-6694-7125zb307ctc@163.com

Chen Hu, M.D., Ph.D.

CONTACT

+86-010-6694-7108chenhu217@aliyun.com

Study Design

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

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

CN(1)