Hematopoietic Stem Cell TransplantationNCT06554197
Evaluation of CMV/EBV-CMI in Haploid HSCT
An observational study of Hematopoietic Stem Cell Transplantation and Cytomegalovirus Infections, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) . Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Cytomegalovirus Infections, Epstein-Barr Virus Infections
- What is being tested?
- CMV/EBV-CMI
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 31 Jul 2026
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
Who may be able to join
- All patients were diagnosed with hemopathy.
- All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
- All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.
Who cannot join
- Patients with any conditions not suitable for the trial (investigators' decision).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Feng Chen, PhD, 13584861215, 13584861215@163.com
About this study
Official title: Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .
- Conditions
- Hematopoietic Stem Cell Transplantation, Cytomegalovirus Infections, Epstein-Barr Virus Infections
- Being tested
- CMV/EBV-CMI
- Medical subject headings
- Cytomegalovirus Infections, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV/EBV-CMIDiagnostic test
The CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation.
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV-CMI
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
Measured: 6 months after transplantation
EBV-CMI
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
Measured: 6 months after transplantation
Secondary outcomes (7)
Cumulative incidence of CMV reactivation
The cumulative incidences of CMV reactivation after transplantation.
Measured: 1 years after transplantation
Cumulative incidences of EBV reactivation
The cumulative incidences of EBV reactivation after transplantation
Measured: 1 years after transplantation
Overall survival (OS)
Overall survival (OS) is defined as the time from randomization to death resulting from any cause.
Measured: 1 years after transplantation
Non-relapse mortality (NRM)
Non-relapse mortality (NRM) is defined as the time from enrollment to death of any causes other than hematologic disease relapse.
Measured: 1 years after transplantation
Relapse-related mortality (RRM)
Relapse-related mortality (RRM) is defined as the time from enrollment to death of relapse.
Measured: 1 years after transplantation
GVHD-free and relapse-free survival (GRFS)
GRFS is defined as the time from graft infusion to the onset of grades 3 to 4 aGVHD, moderate to severe cGVHD, or relapse/disease progression/death.
Measured: 1 years after transplantation
Cumulative incidences of aGVHD
The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard.
Measured: 100 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start13 Aug 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554197
- Sponsor's protocol ID
- CMV/EBV-CMI
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06554197
- Acronym / sponsor ID
- CMV/EBV-CMI
- Conditions
- Hematopoietic Stem Cell Transplantation, Cytomegalovirus Infections, Epstein-Barr Virus Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 13 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 15 Aug 2024 (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.
The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
Key inclusion criteria (3 listed)
- All patients were diagnosed with hemopathy.
- All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
- All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.
Key exclusion criteria (1 listed)
- Patients with any conditions not suitable for the trial (investigators' decision).
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 |
|---|---|---|
| CMV/EBV-CMIThe CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation. | Diagnostic test | – |
Primary outcome
CMV-CMI
Time frame: 6 months after transplantation
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
EBV-CMI
Time frame: 6 months after transplantation
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
7 secondary outcomes
Cumulative incidence of CMV reactivation
Time frame: 1 years after transplantation
Cumulative incidences of EBV reactivation
Time frame: 1 years after transplantation
Overall survival (OS)
Time frame: 1 years after transplantation
Non-relapse mortality (NRM)
Time frame: 1 years after transplantation
Relapse-related mortality (RRM)
Time frame: 1 years after transplantation
GVHD-free and relapse-free survival (GRFS)
Time frame: 1 years after transplantation
Cumulative incidences of aGVHD
Time frame: 100 days after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
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 Hematopoietic Stem Cell Transplantation and Cytomegalovirus Infections, run by The First Affiliated Hospital of Soochow University 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 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 15 Aug 2024. 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 Feng Chen, PhD (13584861215, 13584861215@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV-CMI (time frame: 6 months after transplantation). The study lists 2 primary outcomes in all. 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 15 Aug 2024.