Acute LeukemiaNCT04298502
The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human
An observational study of Acute Leukemia and CMV Viremia, run by Peking University People's Hospital at 1 site in China.
Trial summary
This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Leukemia, CMV Viremia, Hematopoietic Stem Cell Transplantation
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation AND the healthy donors.
Who may be able to join
- AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
- No severe organ dysfunction or failure
- Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.
Who cannot join
- Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.
- Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044
Xiangyu Zhao
About this study
This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection
Read the detailed description
According to the changes of molecular and gene expression in NK cells at different time points after infection, we want to find out the mechanism by which HCMV promotes the expansion of NKG2C + NK cells.
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV viremia
CMV-DNA>1.0x10^3 cpies/mL
Measured: 2 moths post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2020 (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 Acute LeukemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
- Investigators
- Xiaojun Huang, M.D., PhD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298502
- Sponsor's protocol ID
- HCMV-NKG2C+ NK cell
- Status last verified
- Sep 2020
- First submitted
- 4 Mar 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human
- ClinicalTrials.gov ID
- NCT04298502
- Acronym / sponsor ID
- HCMV-NKG2C+ NK cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 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.
This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection
Detailed description
According to the changes of molecular and gene expression in NK cells at different time points after infection, we want to find out the mechanism by which HCMV promotes the expansion of NKG2C + NK cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation AND the healthy donors.
Key inclusion criteria (3 listed)
- AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
- No severe organ dysfunction or failure
- Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.
Key exclusion criteria (2 listed)
- Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.
- Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CMV viremia
Time frame: 2 moths post-transplantation
CMV-DNA>1.0x10^3 cpies/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
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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.
Xiaojun Huang, M.D., PhD study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and CMV Viremia, 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 3 inclusion and 2 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 1 Oct 2020. 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 Xiangyu Zhao, M.D., PhD (+8610-88325949, xyz80421@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV viremia (time frame: 2 moths 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 1 Oct 2020.