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Trial record 19 of 300 for:    "Cytomegalic inclusion disease"

CMV-CTL for the Treatment of CMV Infection After HSCT

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ClinicalTrials.gov Identifier: NCT03004261
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
Liping Wan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Hematological Disease Biological: donor derived cytomegalovirus specific T lymphocytes Drug: Foscarnet Drug: Ganciclovir Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cytomegalovirus Specific Cytotoxic T Lymphocyte for the Treatment of Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
Study Start Date : November 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
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.
Biological: donor derived cytomegalovirus specific T lymphocytes
donor derived cytomegalovirus specific T lymphocytes will be transfused to recipients of hematopoietic stem cell transplant when they are sero-positive for CMV-DNA.
Other Name: cytomegalovirus specific T lymphocytes

Drug: Foscarnet
Foscarnet may be used for the treatment of CMV infection before and after the CMV-CTL infusion.

Drug: Ganciclovir
Ganciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion.




Primary Outcome Measures :
  1. 30-day response rate [ Time Frame: from the date of CMV-CTL infusion to 30 days after the infusion ]
    The percentage of patient whose serum CMV-DNA becomes negative in 30 days.


Secondary Outcome Measures :
  1. 1-year overall survival [ Time Frame: from the date of transplant to 1 year after transplant ]
    The length of patients who are alive in 1 years.

  2. 100-day incidence of acute GVHD [ Time Frame: from the date of transplant to 100 days after transplant ]
    the incidence of acute GVHD

  3. 1-year incidence of chronic GVHD [ Time Frame: from the date of transplant to 1 year after transplant ]
    the incidence of chronic GVHD



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004261


Contacts
Contact: Liping Wan, M.D.,Ph.D. 862137798987 wanliping924@hotmail.com
Contact: Chun Wang, M.D.,Ph.D. 862137798987 wangchunsgh@126.com

Locations
China, Shanghai
Shanghai Jiao Tong University Affilated Shanghai General Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Xingpeng Wang, M.D, Ph.D    63069298    sfph_edu2@163.com   
Contact: Yanhong Zhu, M.S    63240090 ext 6213    sfph_edu2@shmu.edu.cn   
Sub-Investigator: Liping Wan, M.D., Ph.D.         
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
Principal Investigator: Liping Wan, M.D.,Ph.D. Shanghai Jiao Tong University Affiliated Shanghai General Hospital

Responsible Party: Liping Wan, Chief Physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03004261     History of Changes
Other Study ID Numbers: CMV-CTL-201609
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Liping Wan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
cytomegalovirus infection
cytotoxic T lymphocyte
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Cytomegalovirus Infections
Infection
Communicable Diseases
Hematologic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Foscarnet
Phosphonoacetic Acid
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents