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ACCL21C2, Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults with Cancer

Primary Investigator
Goldman, Joshua
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT05228275
UM Number
2023.089
Age Group
Children
Management Group
CTSU - Oncology
Oncology Group
Childhood Cancers
ID (Protocol)
50436
Secondary Protocol No
HUM00242214
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Hodgkin's Lymphoma
Ill-Defined Sites
Kaposi's Sarcoma
Kidney
Larynx
Leukemia, other
Lip, Oral Cavity and Pharynx
Liver
Lung
Lymphoid Leukemia
Melanoma, Skin
Multiple Myeloma
Mycosis Fungoides
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Hematopoietic
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder
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 a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or "boosts" (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.

Eligibility: Inclusion Criteria
  •   * >= 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 Criteria
  •   * 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