Status:
UNKNOWN
To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Breast Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy w...
Eligibility Criteria
Inclusion
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age ≥ 18 years
- Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.
- Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4
- Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
- Therapy may be neo/adjuvant or for metastatic disease
- Eastern Cooperation Oncology Group (ECOG) Performance status (PS) of 0-2
Exclusion
- \* Life expectancy of \< 12 months
Key Trial Info
Start Date :
February 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 28 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04821570
Start Date
February 23 2021
End Date
March 28 2025
Last Update
April 4 2023
Active Locations (1)
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1
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205