Multi-virus (Cytomegalovirus, EB virus, Adenovirus, BK virus, and HHV-6) specific Cytotoxic T-Lymphocytes from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after hematopoietic cell transplantation (multi-center, prospective phase I/II study)
- Conditions
- Persistent viral infection after Hematopoietic cell transplanation
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 3
Not provided
1)ATG, Campath-1H or other anti-T cell monoclonal antibodies within 28 days before the entry. 2)Severe infectious diseases except for ADV, BKV, CMV, EBV, or HHV6 infection. 3)Donor lymphocyte infusion within 28 days before the entry 4)Uncontrollable acute GVHD (grade III-IV) despite standard immunosuppressive therapy (for example; prednisolone up to 0.5mg/kg/day) 5)Relapse of hematological malignancy that is considered as an indication for HSCT 6)History of malignancy, except for (1) the patients malignancy that is to be treated with HCT, (2) malignancy in remission for more than 5 years or (3) totally resected GI or skin cancer 7)SpO2 on room air < 90% 8)Patients with any of the following pulmonary function tests (PFT) results: i) FEV1/vital capacity < 70% for 16 years and older, and < 80% for age between 6 years and 15 years. ii) %VC <80% iii) FEV1 <75% of predicted with 10% decline compared before HCT. 9)Incidence of bronchiolitis obliterans (BO), or bronchiolitis obliterans syndrome (BOS) on high-resolution computed tomography. 10)KL-6 >500U/mL for patients 16 years and older, and >250U/mL for patients 15 years and under 11)Smoking after HSCT 12)Ejection fraction less than 40% 13)Patient judged not eligible for this study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event rate (during the 30 days after the final intervention, >=CTCAev4.0 Grade3) Acute GVHD (Grade III-IV) rate (during the 45 days after the final intervention)
- Secondary Outcome Measures
Name Time Method 1) Determination of recommended cell dose of transfusion 2) Chronic GVHD rate (during the 1 year after the final intervention) 3) Improvement of clinical symptoms and reduction rate of viral load(during the 30 days after the final intervention) 4) Count of Virus-specific T-cells(at 2, 4, 12 weeks after the intervention) 5) Improvement of clinical symptoms (at 6 and 12 weeks after the final intervention) 6) Overall survival rate (at 6 months and 12 months after the final intervention)