CMV ViremiaNCT04320303
CMV Infection and Immune Intervention After Transplantation
A study testing expanded NK cells in people with CMV Viremia and Transplantation Infection, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CMV Viremia, Transplantation Infection
- What is being tested?
- expanded NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Donor age 16-65 years
- Patient Karnofsky score> 70%
- Estimated survival> 3 weeks
- Patient agrees to participate in study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044
Xiang-Yu Zhao, M.D., PhD, +861088325949, zhao_xy@bjmu.edu.cn
About this study
Official title: CMV Infection and Immune Intervention After Haploidentical Hematopoietic Stem Cell Transplantation
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.
- Conditions
- CMV Viremia, Transplantation Infection
- Being tested
- expanded NK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expanded NK cellsBiological
Donor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation.
| Study group | Role | What they receive |
|---|---|---|
| adaptive NK cells infusion post transplantation | Experimental | Adaptive donors expanded NK cells infusion at day 20±3d and 27±3d post transplantation Receives: Biological: expanded NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of CMV infection post transplantation
Whether to reduce the incidence of CMV infection in patients post haploidentical transplantation
Measured: within 180 days post transplantation
Secondary outcomes (6)
Cumulative incidence of refractory CMV infection post transplantation
Whether to reduce the incidence of refractory CMV infection in patients post haploidentical transplantation
Measured: within 180 days post transplantation
Cumulative incidence of CMV disease post transplantation
Whether to reduce the incidence of CMV disease in patients post haploidentical transplantation
Measured: within 180 days post transplantation
Enhanced anti-CMV function of reconstituted NK cells
Whether to enhance the anti-CMV function of reconstituted NK cells
Measured: within 180 days post transplantation
cumulative incidence of TRM
Whether to reduce the incidence of transplantation related mortality in patients post haploidentical transplantation
Measured: within 180 days post transplantation
cumulative incidence of overall survival
Whether to increase the incidence of overall survival in patients post haploidentical transplantation
Measured: within 180 days post transplantation
cumulative incidence of disease free survival
Whether to increase the incidence of disease free survival in patients post haploidentical transplantation
Measured: within 180 days post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start23 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV ViremiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang,MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320303
- Sponsor's protocol ID
- 2016PhB175-01
- Status last verified
- Jun 2021
- First submitted
- 23 Mar 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMV Infection and Immune Intervention After Haploidentical Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04320303
- Acronym / sponsor ID
- 2016PhB175-01
- Conditions
- CMV Viremia, Transplantation Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adaptive NK cells infusion post transplantation | Experimental | Biological: expanded NK cellsAdaptive donors expanded NK cells infusion at day 20±3d and 27±3d post transplantation |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expanded NK cellsDonor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation. | Biological | adaptive NK cells infusion post transplantation |
Primary outcome
Cumulative incidence of CMV infection post transplantation
Time frame: within 180 days post transplantation
Whether to reduce the incidence of CMV infection in patients post haploidentical transplantation
6 secondary outcomes
Cumulative incidence of refractory CMV infection post transplantation
Time frame: within 180 days post transplantation
Cumulative incidence of CMV disease post transplantation
Time frame: within 180 days post transplantation
Enhanced anti-CMV function of reconstituted NK cells
Time frame: within 180 days post transplantation
cumulative incidence of TRM
Time frame: within 180 days post transplantation
cumulative incidence of overall survival
Time frame: within 180 days post transplantation
cumulative incidence of disease free survival
Time frame: within 180 days post transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expanded NK cells in people with CMV Viremia and Transplantation Infection, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang-Yu Zhao (861088325949, zhao_xy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of CMV infection post transplantation (time frame: within 180 days post transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.