Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
NCT ID: NCT04930055
Last Updated: 2023-05-19
Study Results
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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TERMINATED
2206 participants
OBSERVATIONAL
2021-06-30
2022-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Patients with solid tumors receiving courses of cytotoxic therapy.
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 2
Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 3
Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 4
Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 5
Patients receiving immune checkpoint inhibitors.
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 6
Patients who underwent allogeneic stem cell transplant within 12 months.
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 7
Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months.
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 8
Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 9
Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 10
Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 11
Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Group 12
Patients who have a cancer diagnosis but do not fall into group 1-11
COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Interventions
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COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
3. Subjects must be ≥ 18 years old at the time of consent.
4. Diagnosis of cancer and fall into one of the groups below:
1. Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
2. Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
3. Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
4. Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
5. Group 5: Patients receiving immune checkpoint inhibitors.
6. Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
7. Group 7: Patients who underwent cellular therapy, including Chimeric antigen receptor t-cells (CAR-T) cells or t-cells with engineered t-cell receptors (TCRs) within 12 months.
8. Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
9. Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
10. Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
11. Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
12. Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11
3\. Estimated survival of 8 weeks or more following enrollment on the study.
Exclusion Criteria
2. Unwilling or unable to follow protocol requirements.
18 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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Utpal P. Davé
Associate Professor Department of Medicine Division of Hematology/Oncology
Principal Investigators
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Utpal Dave, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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CTO-IUSCCC-0759
Identifier Type: -
Identifier Source: org_study_id
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