CMV-CTL for the Treatment of CMV Infection After HSCT
Condition: Cytomegalovirus Infections; Hematological Disease
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections; Hematologic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for
      recipients of allogeneic hematopoietic stem cell transplantation(HSCT). we propose to study
      the immunologic and virologic effects of donor derived CMV specific cytotoxic T lymphocyte
      (CMV-CTL) given to transplant recipients

      CMV antigen peptides will be used to induce the CMV antigen specific T lymphocytes derived
      from donor peripheral blood mononuclear cells for a period of 18~21 days.The patients will
      receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The
      CMV-DNA level will be monitored weekly after transfusion.
    

Detailed description: 
      Allogeneic hematopoietic stem cell transplantation is widely used for the treatment of
      hematological malignancies and bone marrow failure diseases. Human cytomegalovirus (CMV)
      infection is a major cause of morbidity and mortality for recipients of allogeneic
      hematopoietic stem cell transplantation(HSCT). Approximately half of the recipients would
      develop CMV infection after transplant. Present treatment recommendation for CMV infection
      including ganciclovir and foscarnet. However, these medications have many side effects, the
      most serious is myelosuppression and renal injury, moreover, many patients do not response to
      these medications. Considering the risk associated with persistent infection and the
      potential for CMV specific cytotoxic T lymphocyte (CMV-CTL) to restore immunity, we propose
      to study the immunologic and virologic effects of donor derived CMV-CTL given to transplant
      recipients, levels of CMV-CTL and CMV DNA will be measured from CTL recipients.

      If the patient and their donor are eligible, we will take 80 ml of fresh blood from the donor
      or 5 ml peripheral blood stem cell from the donor.The peripheral blood mononuclear cells will
      be separated from peripheral blood or peripheral blood stem cell. CMV antigen peptides will
      be used to induce the CMV-CTL for a period of 18~21 days.

      The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The
      patients will receive the dose of 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 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, Foscarnet.
    

Intervention name(s): donor derived cytomegalovirus specific T lymphocytes; Foscarnet; Ganciclovir
Intervention type(s): Biological; Drug; Drug
Intervention description(s): donor derived cytomegalovirus specific T lymphocytes will be transfused to recipients of hematopoietic stem cell transplant when they are sero-positive for CMV-DNA.; Foscarnet may be used for the treatment of CMV infection before and after the CMV-CTL infusion.; Ganciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion.
Other intervention name(s): cytomegalovirus specific T lymphocytes
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate; Foscarnet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cytomegalovirus infection; cytotoxic T lymphocyte; hematopoietic stem cell transplantation