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

Hematologic Diseases Clinical Trial

Official title:

Clinical Study on the Impact of Covid-19 Vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Sem Cell Transplantation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05587881
• Other study ID #: 2019-nCoVvaccine 01
• Status: Withdrawn
• Start date: January 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Hematologic Diseases

Intervention

Biological:
• COVID-19 vaccine(donor)
Donor received COVID-19 vaccine before stem cells collection.
• COVID-19 vaccine(patient)
Patient received COVID-19 vaccine before allo-HSCT.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival(PFS)	To measure the duration of response to allo-HSCT over a follow-up period of 12 months.	up to 12 months
Secondary	Overall Survival(OS)	OS will be assessed from the first day of stem cells infused to death or last follow-up.	up to 12 months
Secondary	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 12 months after stem cells infused