Persistent viral infection after Hematopoietic cell transplanation
Conditions
Interventions
Multi-virus specific CTL to persistent viral infection after hematopoietic cell transplantation
Sponsors
Medical Hospital, Tokyo Medical and Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for case 1)Time post hematopoietic cell transplantation is between 30 days and 12 months. 2)Refractory to standard anti-viral therapies for ADV, BKV, CMV, EBV, HHV6 3)Acute GVHD is grade I and under or chronic GVHD is moderate and under, with steroid (prednisolone) less than 0.5mg/kg/day 4)Obtained informed consent from a patient (20 years old and over) and/or a guardian of the patient (under-20 years old). 5)No noninfectious pulmonary complications (NIPCs) Inclusion criteria for donor 1)Cognate parents or sibling or child with age between 10 and 69 years old 2)Related donor of allogenic hematopoietic cell transplantation for the recipient or HLA-haploidentical or more HLA-matched relative donor 3)Meeting the eligibility criterion for blood donation of Japanese Red Cross Society 4)Obtained informed consent from a patient (20 years old and over) and/or a guardian of the patient (under-20 years old) and inform assent (10 years old and over) 5)Not applicable for the following criteria (1) Poor physical condition at the day of donation (2) Dental therapy with bleeding within 3 days before the donation (3) Cancer under treatment or within one year after treatment (4) Hematological disorder (5) Primary immunological disorder (6) Collagen disease (7) Autoimmune disorder (8) Recipient of organ transplantation (9) Carrier (or be suspected) for viruses such as HIV or hepatitis virus (10) Creutzfeldt-Jakob disease (CJD) or suspected for CJD (11) On immunosuppressant (12) Piercing or tattooed within 6 months
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactTomohiro Morio
Medical Hospital, Tokyo Medical and Dental University Department of Pediatrics
Outcome results
None listed