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

Study Overview
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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.

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

Conditions
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Hematologic Diseases

Intervention / Treatment
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* Biological: COVID-19 vaccine(donor)
* Biological: COVID-19 vaccine(patient)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Allogeneic hematopoietic stem cell transplantation is expected to start in the short term. Able and willing to provide written informed consent and comply with all requirements for study participation (including all study procedures). Exclusion Criteria: Patients or donors with a history of previous infection with SARS-Cov-2. Patients or donors are currently infected with SARS-Cov-2. Patients have a history of other malignancies, disease progression, or is currently on systemic therapy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| donor with vaccine, patient without vaccine<br>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)<br>* Donor received COVID-19 vaccine before stem cells collection.<br>|
| donor without vaccine, patient with vaccine<br>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)<br>* Donor received COVID-19 vaccine before stem cells collection.<br>Biological: COVID-19 vaccine(patient)<br>* Patient received COVID-19 vaccine before allo-HSCT.<br>|
| donor with vaccine, patient with vaccine<br>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)<br>* Patient received COVID-19 vaccine before allo-HSCT.<br>|
| donor without vaccine, patient without vaccine<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allo-HSCT, Covid-19 vaccine