Status:
UNKNOWN
COVID-19 Vaccine in Patients After Allogeneic HCT, CAR-T Therapy and With Primary Immune Deficiency
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Allogenic Hematopoietic Cell Transplant
CAR-T Therapy
Eligibility:
All Genders
18+ years
Brief Summary
The corona pandemic is a continuing global challenge due to Corona Virus 2019 (COVID-19). The purpose of the study is to confirm the accepted hypothesis from the recommendations of The European Socie...
Detailed Description
The study population will be allogeneic bone marrow transplant patients and those who have received CART therapy - immunocompromised patients who are vaccinated with COVID-19 in a commercial preparati...
Eligibility Criteria
Inclusion
- Patients aged 18 and over
- Patient sex - male and female
- Bone marrow transplant from a donor (sibling or unrelated) or after cell therapy (CART) at least 3 months before vaccination.
- Patients with primary immunodeficiency syndrome.
- Patients who are able to sign an informed consent form
Exclusion
- Patients under 18 years of age
- Patients who are unable to give informed consent
- Patients with acute GVHD who require steroid therapy above 0.5 mg / kg or who have been diagnosed in the last month.
- Patients with chronic GVHD who require steroid therapy above 0.5 mg / kg
- Patients treated with rituximab / immunoglobulins / mesenchymal cells during the last month.
- Patients whose disease is not completely cured and receive dedicated treatment for the disease.
- Patients receiving maintenance treatment for the underlying disease (excluding TKIs such as sorfenib, midostaurin, guiltritinib or cranolinib).
- Patients who have previously had COVID19.
- Patients with severe allergy to one of the vaccine components.
Key Trial Info
Start Date :
December 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 28 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04724642
Start Date
December 28 2020
End Date
December 28 2021
Last Update
January 28 2021
Active Locations (1)
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1
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906