Clinical trial
Clinical Study on the Impact of Covid-19 Vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Sem Cell Transplantation
Name
2019-nCoVvaccine 01
Description
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.
Trial arms
Trial start
2022-01-01
Estimated PCD
2023-11-01
Trial end
2023-11-01
Status
Withdrawn
Treatment
COVID-19 vaccine(donor)
Donor received COVID-19 vaccine before stem cells collection.
Arms:
donor with vaccine, patient without vaccine, donor without vaccine, patient with vaccine
COVID-19 vaccine(patient)
Patient received COVID-19 vaccine before allo-HSCT.
Arms:
donor with vaccine, patient with vaccine, donor without vaccine, patient with vaccine
Primary endpoint
Disease-free Survival(PFS)
up to 12 months
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-03-26
1 organization
1 product
1 indication
Product
COVID-19 vaccineIndication
Hematologic Disorders