Natural Killer Cell Mediated ImmunityNCT02978274
Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation
An observational study of Natural Killer Cell Mediated Immunity, run by Peking University People's Hospital at 1 site in China.
Trial summary
Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Natural Killer Cell Mediated Immunity
- What is being tested?
- MMF
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2022
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
Who may be able to join
- AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
Who cannot join
- NR or refractory AML/ALL before transplantation donors from mother or collateral related
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, M.D., PhD, +8610-88325949, xyz80421@126.com
About this study
Official title: Natural Killer Cells Reconstitution Kinetics Post T Cells Repleted Haploidentical Transplantation
Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution.
Read the detailed description
Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60, 90, 180, and 1 year post transplantation.
- Conditions
- Natural Killer Cell Mediated Immunity
- Being tested
- MMF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMFDrug
MMF withdrawal by engraftment post haplo-SCT
MMFDrug
MMF withdrawal by 2 month post haplo-SCT
| Study group | Role | What they receive |
|---|---|---|
| experimental group | MMF withdrawal by engraftment post haplo-SCT Receives: Drug: MMF | |
| control group | MMF withdrawal by 2 month post haplo-SCT Receives: Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Reconstitution differences between two group
Measured: 1 year
Secondary outcomes (7)
Cumulative incidence of Infection differences between two group
Measured: 1 year
Cumulative incidence of acute GVHD differences between two group
Measured: 100 day
Cumulative incidence of chronic GVHD differences between two group
Measured: 1 year
Cumulative incidence of TRM differences between two group
Measured: 1 year
Cumulative incidence of relapse differences between two group
Measured: 1 year
DFS differences between two group
Measured: 1 year
OS differences between two group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Natural Killer Cell Mediated ImmunityStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT02978274
- Sponsor's protocol ID
- 2016PHB038-01
- Status last verified
- Sep 2020
- First submitted
- 28 Nov 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhao XY, Yu XX, Xu ZL, Cao XH, Huo MR, Zhao XS, Chang YJ, Wang Y, Zhang XH, Xu LP, Liu KY, Huang XJ. Donor and host coexpressing KIR ligands promote NK education after allogeneic hematopoietic stem cell transplantation. Blood Adv. 2019 Dec 23;3(24):4312-4325. doi: 10.1182/bloodadvances.2019000242.
PubMed 31869417Kong Y, Wang Y, Zhang YY, Shi MM, Mo XD, Sun YQ, Chang YJ, Xu LP, Zhang XH, Liu KY, Huang XJ. Prophylactic oral NAC reduced poor hematopoietic reconstitution by improving endothelial cells after haploidentical transplantation. Blood Adv. 2019 Apr 23;3(8):1303-1317. doi: 10.1182/bloodadvances.2018029454.
PubMed 31015207
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Killer Cells Reconstitution Kinetics Post T Cells Repleted Haploidentical Transplantation
- ClinicalTrials.gov ID
- NCT02978274
- Acronym / sponsor ID
- 2016PHB038-01
- Conditions
- Natural Killer Cell Mediated Immunity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- 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.
Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution.
Detailed description
Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60, 90, 180, and 1 year post transplantation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Drug: MMFMMF withdrawal by engraftment post haplo-SCT |
| control group | – | Drug: MMFMMF withdrawal by 2 month post haplo-SCT |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
Key inclusion criteria (1 listed)
- AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
Key exclusion criteria (1 listed)
- NR or refractory AML/ALL before transplantation donors from mother or collateral related
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 |
|---|---|---|
| MMFMMF withdrawal by engraftment post haplo-SCT | Drug | experimental group |
| MMFMMF withdrawal by 2 month post haplo-SCT | Drug | control group |
Primary outcome
Immune Reconstitution differences between two group
Time frame: 1 year
7 secondary outcomes
Cumulative incidence of Infection differences between two group
Time frame: 1 year
Cumulative incidence of acute GVHD differences between two group
Time frame: 100 day
Cumulative incidence of chronic GVHD differences between two group
Time frame: 1 year
Cumulative incidence of TRM differences between two group
Time frame: 1 year
Cumulative incidence of relapse differences between two group
Time frame: 1 year
DFS differences between two group
Time frame: 1 year
OS differences between two group
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 31869417Zhao XY, Yu XX, Xu ZL, Cao XH, Huo MR, Zhao XS, Chang YJ, Wang Y, Zhang XH, Xu LP, Liu KY, Huang XJ. Donor and host coexpressing KIR ligands promote NK education after allogeneic hematopoietic stem cell transplantation. Blood Adv. 2019 Dec 23;3(24):4312-4325. doi: 10.1182/bloodadvances.2019000242.
- Derived from this study: PubMed 31015207Kong Y, Wang Y, Zhang YY, Shi MM, Mo XD, Sun YQ, Chang YJ, Xu LP, Zhang XH, Liu KY, Huang XJ. Prophylactic oral NAC reduced poor hematopoietic reconstitution by improving endothelial cells after haploidentical transplantation. Blood Adv. 2019 Apr 23;3(8):1303-1317. doi: 10.1182/bloodadvances.2018029454.
- Individual participant dataSharing planned: Undecided
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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 Natural Killer Cell Mediated Immunity, 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 1 inclusion and 1 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 5 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?
Immune Reconstitution differences between two group (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978274, which also lists 2 linked publications.
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 5 Oct 2020.