Refractory viral infection after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
trial group:viral specific T cells therapy
Sponsors
Shanghai Children’ s Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Age between 1 to 18 years; 2. The patients with recurrence and continuous CMV or ADV infection experienced two weeks of antiviral treatment or intolerance to the treatment after allogeneic hematopoietic stem cell transplantation; 3.Steroids (prednisone) usage of 0.5 mg/kg/day or less; 4.Patients without grade III -IV acute GVHD or generalized chronic GVHD; 5.Have suitable VST donor who can donate peripheral blood mononuclear cells; 6.The patients' parents or guardians have the ability to understand and sign informed consent, willing and able to comply with the study of the program.
Exclusion criteria
Exclusion criteria: 1.Antithymocyte globulin, alenimumab, or other T cell monoclonal antibody were used within 4 weeks for transplant recipients; 2.Patients infected with other active infection including: ? Pulmonary infection not caused by CMV or ADV ( SpO2 <90% ); ?Active HBV or HIV infection; ?Bacteria, fungi or parasites infection; ?CMV and ADV were infected simultaneously; 3.Patients experienced transplantation less than 28 days or received donor lymphocyte infusion within 28 days; 4.Relapse of malignant tumor; 5.Patient has contraindications to the investigational drug and excipients; 6. The estimated survival is over 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median survival time; | — |
Countries
China
Contacts
Public ContactChengjuan Luo
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed