Hematologic DiseasesNCT05587881
Clinical Study on the Impact of Covid-19 Vaccine on Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Hematologic Diseases, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Aim of this study will evaluate the Impact of Covid-19 vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Stem Cell Transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- COVID-19 vaccine(donor) and COVID-19 vaccine(patient)
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Nov 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hematological patients will receive allogeneic hematopoietic stem cell transplantation in short time.
Who may be able to join
- Allogeneic hematopoietic stem cell transplantation is expected to start in the short term.
- Able and willing to provide written informed consent and comply with all requirements for study participation (including all study procedures).
Who cannot join
- Patients or donors with a history of previous infection with SARS-Cov-2.
- Patients or donors are currently infected with SARS-Cov-2.
- Patients have a history of other malignancies, disease progression, or is currently on systemic therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Clinical Study on the Impact of Covid-19 Vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Sem Cell Transplantation
Aim of this study will evaluate the Impact of Covid-19 vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Stem Cell Transplantation.
Read the detailed description
Since the first detection of a Corona Virus Disease 2019 (COVID-19) infection in late 2019, the syndrome coronavirus-2 (SARS-CoV-2) has spread rapidly across the globe, threatening the health and safety of an increasing number of people. The development of the SARS-CoV-2 vaccine has been shown to be effective in reducing the chance of COVID-19 infection and the severity of the disease. To control the COVID-19 pandemic, an increasing number of studies are calling for people to receive the SARS-CoV-2 vaccine, and the Chinese government is also advocating universal vaccination. However, the investigators have found in our work that as vaccination has become more widespread, clinicians have become somewhat confused about whether they can choose someone who has been vaccinated against SARS-CoV-2 as a donor for a bone marrow transplant, and what is the optimal time for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in vaccined hematological patients. This study will evaluate the impact of Covid-19 vaccine on safety and efficacy of hematological patients received allo-HSCT.
- Conditions
- Hematologic Diseases
- Being tested
- COVID-19 vaccine(donor), COVID-19 vaccine(patient)
- Keywords
- Allo-HSCT, Covid-19 vaccine
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccine(donor)Biological
Donor received COVID-19 vaccine before stem cells collection.
COVID-19 vaccine(patient)Biological
Patient received COVID-19 vaccine before allo-HSCT.
| Study group | Role | What they receive |
|---|---|---|
| donor with vaccine, patient without vaccine | Patients don' t receive COVID-19 vaccine before allo-HSCT but whose donors receive one dose or more doses COVID-19 vaccine(s) before stem cell collection. Receives: Biological: COVID-19 vaccine(donor) | |
| donor without vaccine, patient with vaccine | Patients receive one dose or more doses COVID-19 vaccine(s) before allo-HSCT but whose donors don't receive COVID-19 vaccine before stem cell collection. Receives: Biological: COVID-19 vaccine(donor); Biological: COVID-19 vaccine(patient) | |
| donor with vaccine, patient with vaccine | Patients receive one dose or more doses COVID-19 vaccine(s) before allo-HSCT and whose donors also receive one dose or more doses COVID-19 vaccine(s) before stem cell collection. Receives: Biological: COVID-19 vaccine(patient) | |
| donor without vaccine, patient without vaccine | Patients don' t receive COVID-19 vaccine before allo-HSCT and whose donors also don't receive COVID-19 vaccine before stem cell collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival(PFS)
To measure the duration of response to allo-HSCT over a follow-up period of 12 months.
Measured: up to 12 months
Secondary outcomes (2)
Overall Survival(OS)
OS will be assessed from the first day of stem cells infused to death or last follow-up.
Measured: up to 12 months
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on NCI Common Termeinology Criteria for Adverse Events(CTCAE), version 5.0 will be tabulated.
Measured: Measured 12 months after stem cells infused
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jan 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Why it stopped: Now, Most patients and their donor have been infected the COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Depei Wu, M.D, Study chair, The First Affilated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587881
- Sponsor's protocol ID
- 2019-nCoVvaccine 01
- Status last verified
- Jan 2022
- First submitted
- 19 Oct 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Impact of Covid-19 Vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Sem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05587881
- Acronym / sponsor ID
- 2019-nCoVvaccine 01
- Conditions
- Hematologic Diseases
- Keywords
- Allo-HSCT, Covid-19 vaccine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Now, Most patients and their donor have been infected the COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 20 Oct 2022 (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.
Aim of this study will evaluate the Impact of Covid-19 vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Stem Cell Transplantation.
Detailed description
Since the first detection of a Corona Virus Disease 2019 (COVID-19) infection in late 2019, the syndrome coronavirus-2 (SARS-CoV-2) has spread rapidly across the globe, threatening the health and safety of an increasing number of people. The development of the SARS-CoV-2 vaccine has been shown to be effective in reducing the chance of COVID-19 infection and the severity of the disease. To control the COVID-19 pandemic, an increasing number of studies are calling for people to receive the SARS-CoV-2 vaccine, and the Chinese government is also advocating universal vaccination. However, the investigators have found in our work that as vaccination has become more widespread, clinicians have become somewhat confused about whether they can choose someone who has been vaccinated against SARS-CoV-2 as a donor for a bone marrow transplant, and what is the optimal time for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in vaccined hematological patients. This study will evaluate the impact of Covid-19 vaccine on safety and efficacy of hematological patients received allo-HSCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| donor with vaccine, patient without vaccine | – | Biological: COVID-19 vaccine(donor)Patients don' t receive COVID-19 vaccine before allo-HSCT but whose donors receive one dose or more doses COVID-19 vaccine(s) before stem cell collection. |
| donor without vaccine, patient with vaccine | – | Biological: COVID-19 vaccine(donor), Biological: COVID-19 vaccine(patient)Patients receive one dose or more doses COVID-19 vaccine(s) before allo-HSCT but whose donors don't receive COVID-19 vaccine before stem cell collection. |
| donor with vaccine, patient with vaccine | – | Biological: COVID-19 vaccine(patient)Patients receive one dose or more doses COVID-19 vaccine(s) before allo-HSCT and whose donors also receive one dose or more doses COVID-19 vaccine(s) before stem cell collection. |
| donor without vaccine, patient without vaccine | – | –Patients don' t receive COVID-19 vaccine before allo-HSCT and whose donors also don't receive COVID-19 vaccine before stem cell collection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hematological patients will receive allogeneic hematopoietic stem cell transplantation in short time.
Key inclusion criteria (2 listed)
- Allogeneic hematopoietic stem cell transplantation is expected to start in the short term.
- Able and willing to provide written informed consent and comply with all requirements for study participation (including all study procedures).
Key exclusion criteria (3 listed)
- Patients or donors with a history of previous infection with SARS-Cov-2.
- Patients or donors are currently infected with SARS-Cov-2.
- Patients have a history of other malignancies, disease progression, or is currently on systemic therapy.
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 |
|---|---|---|
| COVID-19 vaccine(donor)Donor received COVID-19 vaccine before stem cells collection. | Biological | donor with vaccine, patient without vaccine, donor without vaccine, patient with vaccine |
| COVID-19 vaccine(patient)Patient received COVID-19 vaccine before allo-HSCT. | Biological | donor with vaccine, patient with vaccine, donor without vaccine, patient with vaccine |
Primary outcome
Disease-free Survival(PFS)
Time frame: up to 12 months
To measure the duration of response to allo-HSCT over a follow-up period of 12 months.
2 secondary outcomes
Overall Survival(OS)
Time frame: up to 12 months
Adverse events profile
Time frame: Measured 12 months after stem cells infused
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
Depei Wu, M.D study chair
The First Affilated Hospital of Soochow University
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 Hematologic Diseases, 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival(PFS) (time frame: up to 12 months). 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 26 Mar 2024.