Clinical trial NCT05587881: Clinical Study on the Impact of Covid-19 Vaccine on Allogeneic Hematopoietic Stem Cell Transplantation
Official title: Clinical Study on the Impact of Covid-19 Vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Sem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hematologic Diseases
Keywords: Allo-HSCT
Covid-19 vaccine
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematological patients will receive allogeneic hematopoietic stem cell transplantation in short time.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free Survival(PFS)
timeFrame: up to 12 months
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: up to 12 months
measure: Adverse events profile
timeFrame: Measured 12 months after stem cells infused
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affilated Hospital of Soochow University
name: Depei Wu, M.D
role: STUDY_CHAIR
References: