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Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment

A

Auxilio Mutuo Cancer Center

Status

Unknown

Conditions

Covid19
Cancer
HIV Infections

Treatments

Diagnostic Test: Laboratory Samples

Study type

Observational

Funder types

Other

Identifiers

NCT04779996
CCAM 21-01

Details and patient eligibility

About

This is a Phase II study designed to investigate if the Covid 19 vaccines are capable of eliciting production of antibodies against S protein of Sar-S-Cov-2 virus among patients with medical history of cancer previously treated with monoclonal anti CD-20 antibodies. The antibody production is defined based on the detection of antibodies in the serologic Covid-19 rapid test against S protein or with semiquantitative assay when it becomes available.

Enrollment

250 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients either diagnosed with cancer or with HIV positivity or treated with an antineoplastic regimen including anti CD-20 after Covid-19 vaccine will be registered on the study regardless of their type of cancer or type of antineoplastic regimen.
  • Patients 21 years or older diagnosed with cancer treated with antineoplastic regimen or anti CD-20, or with HIV infection vaccinated with 2 doses of anti Covid-19 vaccine.
  • Eligible patients will be registered on study after a Covid -19 vaccine has been scheduled.
  • In order to be screened for Covid 19 antibodies, they must be tested at least two weeks after the second dose of Covid-19 vaccination.

Exclusion criteria

  • Anyone who has not been treated with anti-CD20 antibodies or with chemotherapy who doesn't have HIV infection or who has not received chemotherapy for cancer.

Trial contacts and locations

1

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Central trial contact

Carmen Morales; Fernando Cabanillas, MD

Data sourced from clinicaltrials.gov

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