CMV Infection and Immune Intervention After Transplantation
Primary Purpose
CMV Viremia, Transplantation Infection
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
expanded NK cells
Sponsored by
About this trial
This is an interventional prevention trial for CMV Viremia
Eligibility Criteria
Inclusion Criteria:
- Patients with acute leukemia (AL) or myelodysplastic syndrome (MDS) or myeloma or lymphoma undergoing haploidentical allogeneic stem cell transplantation
- No CMV infection by 20 days ± 3 days after transplantation
- No active acute GVHD by 20 days ± 3 days after transplantation
- The dose of prednisolone was less than 0.5mg / kg / d within 72 hours before and after infusion of NK cells
- Prior to transplantation, the CMV IgG of the recipient and donor were positive, and the recipient had a suitable donor to expand NK cells.
- Patient age 16-65 years
- Donor age 16-65 years
- Patient Karnofsky score> 70%
- Estimated survival> 3 weeks
- Patient agrees to participate in study
Exclusion Criteria:
- Participants in any other clinical trials within 1 month before enrollment
- Active infection
- HBV or HCV or HIV carriers
- With moderate to severe renal dysfunction (blood creatinine> 130umol / L) and / or liver dysfunction (total bilirubin> 34umol / L, ALT, AST> 2 times the upper limit of normal) before NK infusion
- Researchers do not consider it appropriate to participate in this trial.
Sites / Locations
- Peking University Institute of HematologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adaptive NK cells infusion post transplantation
Arm Description
Adaptive donors expanded NK cells infusion at day 20±3d and 27±3d post transplantation
Outcomes
Primary Outcome Measures
Cumulative incidence of CMV infection post transplantation
Whether to reduce the incidence of CMV infection in patients post haploidentical transplantation
Secondary Outcome Measures
Cumulative incidence of refractory CMV infection post transplantation
Whether to reduce the incidence of refractory CMV infection in patients post haploidentical transplantation
Cumulative incidence of CMV disease post transplantation
Whether to reduce the incidence of CMV disease in patients post haploidentical transplantation
Enhanced anti-CMV function of reconstituted NK cells
Whether to enhance the anti-CMV function of reconstituted NK cells
cumulative incidence of TRM
Whether to reduce the incidence of transplantation related mortality in patients post haploidentical transplantation
cumulative incidence of overall survival
Whether to increase the incidence of overall survival in patients post haploidentical transplantation
cumulative incidence of disease free survival
Whether to increase the incidence of disease free survival in patients post haploidentical transplantation
Full Information
NCT ID
NCT04320303
First Posted
March 23, 2020
Last Updated
June 10, 2021
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04320303
Brief Title
CMV Infection and Immune Intervention After Transplantation
Official Title
CMV Infection and Immune Intervention After Haploidentical Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective or even the only way to cure blood malignant diseases. Cytomegalovirus (CMV) infection is a serious early complication of allo-HSCT. Its high incidence and poor prognosis can cause a series of terminal organ diseases such as CMV pneumonia, encephalitis, and enteritis,which seriously affecting the prognosis of patients post allo-HSCT.
Our data show that rapid reconstruction of NK cells after transplantation can reduce the incidence of CMV infection. Patients with a rapid reconstruction of NKG2C after transplantation have a low CMV infection rate, and patients with strong secretion of IFN-gamma of NK after transplantation have low CMV infection.
Our previous research showed that trophoblast cells transfected with IL-21 and 4-1BBL can achieve a large number of clinical-grade expansion of NK cells (mIL-21 / 4-1BBL NK cells), and mIL-21 / 4-1BBL NK cells It is safe to treat patients with minimal residual disease (MRD) positive AML after transplantation, and can induce MRD to turn negative. Previous studies have shown that adoptive infusion of expanded NK cells after haplotype transplantation is safe and can improve the functional reconstruction of NK cells. Therefore, we hypothesized that the infusion of NK cells can improve the antiviral capacity of NK cells, thereby effectively reducing the CMV infection. Incidence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CMV Viremia, Transplantation Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adaptive NK cells infusion post transplantation
Arm Type
Experimental
Arm Description
Adaptive donors expanded NK cells infusion at day 20±3d and 27±3d post transplantation
Intervention Type
Biological
Intervention Name(s)
expanded NK cells
Intervention Description
Donor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation.
Primary Outcome Measure Information:
Title
Cumulative incidence of CMV infection post transplantation
Description
Whether to reduce the incidence of CMV infection in patients post haploidentical transplantation
Time Frame
within 180 days post transplantation
Secondary Outcome Measure Information:
Title
Cumulative incidence of refractory CMV infection post transplantation
Description
Whether to reduce the incidence of refractory CMV infection in patients post haploidentical transplantation
Time Frame
within 180 days post transplantation
Title
Cumulative incidence of CMV disease post transplantation
Description
Whether to reduce the incidence of CMV disease in patients post haploidentical transplantation
Time Frame
within 180 days post transplantation
Title
Enhanced anti-CMV function of reconstituted NK cells
Description
Whether to enhance the anti-CMV function of reconstituted NK cells
Time Frame
within 180 days post transplantation
Title
cumulative incidence of TRM
Description
Whether to reduce the incidence of transplantation related mortality in patients post haploidentical transplantation
Time Frame
within 180 days post transplantation
Title
cumulative incidence of overall survival
Description
Whether to increase the incidence of overall survival in patients post haploidentical transplantation
Time Frame
within 180 days post transplantation
Title
cumulative incidence of disease free survival
Description
Whether to increase the incidence of disease free survival in patients post haploidentical transplantation
Time Frame
within 180 days post transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with acute leukemia (AL) or myelodysplastic syndrome (MDS) or myeloma or lymphoma undergoing haploidentical allogeneic stem cell transplantation
No CMV infection by 20 days ± 3 days after transplantation
No active acute GVHD by 20 days ± 3 days after transplantation
The dose of prednisolone was less than 0.5mg / kg / d within 72 hours before and after infusion of NK cells
Prior to transplantation, the CMV IgG of the recipient and donor were positive, and the recipient had a suitable donor to expand NK cells.
Patient age 16-65 years
Donor age 16-65 years
Patient Karnofsky score> 70%
Estimated survival> 3 weeks
Patient agrees to participate in study
Exclusion Criteria:
Participants in any other clinical trials within 1 month before enrollment
Active infection
HBV or HCV or HIV carriers
With moderate to severe renal dysfunction (blood creatinine> 130umol / L) and / or liver dysfunction (total bilirubin> 34umol / L, ALT, AST> 2 times the upper limit of normal) before NK infusion
Researchers do not consider it appropriate to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang-Yu Zhao
Phone
861088325949
Email
zhao_xy@bjmu.edu.cn
Facility Information:
Facility Name
Peking University Institute of Hematology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang-Yu Zhao, M.D., PhD
Phone
+861088325949
Email
zhao_xy@bjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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CMV Infection and Immune Intervention After Transplantation
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