CMV-CTL for the Treatment of CMV Infection After HSCT
Cytomegalovirus Infections, Hematological Disease
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring cytomegalovirus infection, cytotoxic T lymphocyte, hematopoietic stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
- Any allogeneic stem cell transplant recipient ≥ 14 years of age and ≤ 60 years of age
- Bilirubin/ SGOT/SGPT < 5 × upper normal limits.
- Creatinine < 2 × upper normal limits.
- Ejection fraction ≥ 50%, no severe arrhythmia.
- Estimated life expectancy ≥ 6 months.
- Patients' CMV-DNA ≥ 1000cp/ml in treatment group and being negative in prophylactic group.
Exclusion Criteria:
- Patients receiving prednisone ≥ 1mg/kg/d for the treatment of acute GVHD or mild, severe chronic GVHD.
- Recipient < 14years of age
- Donor is sero-positive in HBV/HCV/HIV or RPR.
Sites / Locations
- Shanghai Jiao Tong University Affilated Shanghai General Hospital
Arms of the Study
Arm 1
Experimental
CMV-CTL
The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The CMV-DNA levels will be monitored weekly for at least 60 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive one additional injection of CMV-CTLs. If the CMV levels in the blood continue to rise after the dose of T cells then the patient will receive treatment with Ganciclovir or Foscarnet.