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

NCT05587881 | Withdrawn

• 1 other identifier: 2019-nCoVvaccine 01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Diseases

Keywords

Allo-HSCT; Covid-19 vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival(OS)

  up to 12 months

• Adverse events profile

  Measured 12 months after stem cells infused

Study Arms (4)

donor with vaccine, patient without vaccine

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)

donor without vaccine, patient with vaccine

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); Biological: COVID-19 vaccine(patient)

donor with vaccine, patient with vaccine

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)

donor without vaccine, patient without vaccine

Patients don' t receive COVID-19 vaccine before allo-HSCT and whose donors also don't receive COVID-19 vaccine before stem cell collection.

Interventions

COVID-19 vaccine(donor) BIOLOGICAL

Donor received COVID-19 vaccine before stem cells collection.

donor with vaccine, patient without vaccine; donor without vaccine, patient with vaccine

COVID-19 vaccine(patient) BIOLOGICAL

Patient received COVID-19 vaccine before allo-HSCT.

donor with vaccine, patient with vaccine; donor without vaccine, patient with vaccine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hematological patients will receive allogeneic hematopoietic stem cell transplantation in short time.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Depei Wu, M.D

  The First Affilated Hospital of Soochow University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 20, 2022
• Study Start: January 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 26, 2024

Record last verified: 2022-01

Locations

CN (1)