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

March 25, 2024 updated by: The First Affiliated Hospital of Soochow University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hematological patients will receive allogeneic hematopoietic stem cell transplantation in short time.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: COVID-19 vaccine(donor)
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.
Biological: COVID-19 vaccine(donor)
Donor received COVID-19 vaccine before stem cells collection.
Biological: COVID-19 vaccine(patient)
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.
Biological: COVID-19 vaccine(patient)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival(OS)
Time Frame: up to 12 months
OS will be assessed from the first day of stem cells infused to death or last follow-up.
up to 12 months
Adverse events profile
Time Frame: Measured 12 months after stem cells infused
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 12 months after stem cells infused

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Study Chair: Depei Wu, M.D, The First Affilated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-nCoVvaccine 01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematologic Diseases

Clinical Trials on COVID-19 vaccine(donor)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe