Clinical Study on the Impact of Covid-19 Vaccine on Allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT05587881

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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

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Hematologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

COVID-19 vaccine(donor)

Intervention Type BIOLOGICAL

Donor received COVID-19 vaccine before stem cells collection.

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.

COVID-19 vaccine(donor)

Intervention Type BIOLOGICAL

Donor received COVID-19 vaccine before stem cells collection.

COVID-19 vaccine(patient)

Intervention Type BIOLOGICAL

Patient received COVID-19 vaccine before allo-HSCT.

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.

COVID-19 vaccine(patient)

Intervention Type BIOLOGICAL

Patient received COVID-19 vaccine before allo-HSCT.

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.

No interventions assigned to this group

Interventions

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COVID-19 vaccine(donor)

Donor received COVID-19 vaccine before stem cells collection.

Intervention Type BIOLOGICAL

COVID-19 vaccine(patient)

Patient received COVID-19 vaccine before allo-HSCT.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Allogeneic hematopoietic stem cell transplantation is expected to start in the short term.
2. Able and willing to provide written informed consent and comply with all requirements for study participation (including all study procedures).

Exclusion Criteria

1. Patients or donors with a history of previous infection with SARS-Cov-2.
2. Patients or donors are currently infected with SARS-Cov-2.
3. Patients have a history of other malignancies, disease progression, or is currently on systemic therapy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Depei Wu, M.D

Role: STUDY_CHAIR

The First Affilated Hospital of Soochow University

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2019-nCoVvaccine 01

Identifier Type: -

Identifier Source: org_study_id

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