Viral Infection Clinical Trial
Official title:
Adoptive Transfer of Peptide Stimulated CMV/EBV Specific Cytotoxic T Lymphocytes to Prevent and Treat EBV/CMV Infections in Patients Post Allogeneic Stem Cell Transplantation in China
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital to Academy of Military Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital to Academy of Military Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | 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 | No |
Secondary | The incidence of ?~?°aGVHD within 30 days after the last dose of CTL infusion | 3 months | Yes | |
Secondary | Reconstitution of antiviral immunity monitored by flow cytometry | 6 months | No | |
Secondary | Number of patients with chronic GVHD | 6 months | Yes |
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