Status:
ACTIVE_NOT_RECRUITING
Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
COVID-19 Infection
Hematopoietic and Lymphatic System Neoplasm
Eligibility:
All Genders
6-37 years
Brief Summary
This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against...
Detailed Description
PRIMARY OBJECTIVE: I. Characterize the immunologic response following severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 vaccination in children, adolescents, and young adults with cancer w...
Eligibility Criteria
Inclusion
- \>= 6 months and =\< 37 years of age at time of enrollment
- Patient plans to receive their first COVID-19 vaccine dose one of the food and drug administration (FDA) approved/FDA-emergency use authorization (EUA) approved COVID-19 vaccines OR patient already received their first COVID-19 vaccine dose =\< 24 months prior to enrollment using one of the FDA approved/FDA-EUA approved COVID-19 vaccines.
- Note: for this observational study, the decision to vaccinate is according to local discretion and should be made prior to consideration of enrollment
- Must have a diagnosis of cancer
- Patient must be undergoing or have previously received one of the following cancer treatments within 12 months before their first COVID-19 vaccine dose:
- Dosing with chemotherapy or immunotherapy agent, including tyrosine kinase inhibitors and small molecule inhibitors targeting cancer
- Dosing with monoclonal antibodies targeting B-cell antigens (e.g., Rituximab), or Bruton tyrosine kinase inhibitors or Janus Kinase inhibitors
- Stem cell infusion for bone marrow transplant or CAR-T infusion for cellular therapy
- A patient enrolling prior to their first COVID-19 vaccine dose is eligible only if it is feasible to collect required baseline study specimens within protocol mandated time period prior to the initial COVID-19 vaccine dose; or a patient who already received a COVID-19 vaccine is eligible only if feasible to collect at least one post-first-dose follow-up specimen (i.e., at minimum, collection of the 24m PFD follow-up specimen must be feasible as per timing requirements
- Note: for this observational study, the vaccine timing and regimen will proceed according to local discretion. Patients enrolled prior to their first COVID-19 vaccine dose who do not receive initial vaccine dose within 3 months after enrollment will be taken off study
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion
- Documented SARS-CoV-2 monoclonal antibody infusion or convalescent plasma after COVID-19 infection within last 90 days
- Note: patients with previous COVID-19 infection are eligible as long as requirements are met. Patients receiving intravenous immunoglobulin therapy (IVIG) therapy (i.e., post bone marrow transplantation \[BMT\] or chimeric antigen receptor \[CAR\]-T) are eligible
- Patients undergoing radiation therapy only are ineligible
- Reminder: before the planned initial COVID-19 vaccine dose, patient must be undergoing or have received cancer treatments
Key Trial Info
Start Date :
April 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT05228275
Start Date
April 8 2022
End Date
September 30 2027
Last Update
December 22 2025
Active Locations (72)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Kingman Regional Medical Center
Kingman, Arizona, United States, 86401
3
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
4
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123