To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment

NCT ID: NCT04821570

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-23

Study Completion Date

2025-03-28

Brief Summary

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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 with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.

Detailed Description

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Conditions

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Breast Cancer Lung Cancer Melanoma (Skin)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Chemotherapy (IV and oral)

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Per recommended dosing schedule

Immunotherapy

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Per recommended dosing schedule

Chemotherapy + Immunotherapy

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Per recommended dosing schedule

Cyclin- dependent kinase (CDK) 4/6 inhibitors

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Per recommended dosing schedule

Stem Cell Transplant recipients

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Per recommended dosing schedule

Interventions

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COVID-19 Vaccine

Per recommended dosing schedule

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

\* Life expectancy of \< 12 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qamar Khan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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IIT-2021-CANINE

Identifier Type: -

Identifier Source: org_study_id

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