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

The First Affiliated Hospital of Soochow University

Overview

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.

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

Conditions

Hematologic Diseases

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Outcomes

Primary Outcomes

Disease-free Survival(PFS)

To measure the duration of response to allo-HSCT over a follow-up period of 12 months.

Time frame: up to 12 months

Secondary Outcomes

Overall Survival(OS)

OS will be assessed from the first day of stem cells infused to death or last follow-up.

Time frame: 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.

Time frame: Measured 12 months after stem cells infused

Data from ClinicalTrials.gov

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