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

Withdrawn

• Conditions: Hematologic Diseases
• Interventions: Biological: COVID-19 vaccine(donor); Biological: COVID-19 vaccine(patient)

• Registration Number: NCT05587881
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief 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.

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 Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-20
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
donor with vaccine, patient without vaccine	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	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	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 with vaccine	COVID-19 vaccine(donor)	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.

Primary Outcome Measures

Name	Time	Method
Disease-free Survival(PFS)	up to 12 months	To measure the duration of response to allo-HSCT over a follow-up period of 12 months.

Secondary Outcome Measures

Name	Time	Method
Adverse events profile	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.
Overall Survival(OS)	up to 12 months	OS will be assessed from the first day of stem cells infused to death or last follow-up.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China