NCT04930055终止不适用
Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,206
- 试验地点
- 2
- 主要终点
- Adverse Event Collection
研究概览
简要总结
The goals of this study are to assess initial or booster vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (PBMCs) pre and post-vaccination to assess immune and other response parameters following immunization in cancer patients receiving either the Pfizer (BTN162b2), Moderna (mRNA-1273), or the Janssen (Ad26.COV2.S) vaccines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent and HIPAA authorization
- •Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
- •Subjects must be ≥ 18 years old at the time of consent.
- •Diagnosis of cancer and fall into one of the groups below:
- •Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
- •Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
- •Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
- •Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
- •Group 5: Patients receiving immune checkpoint inhibitors.
- •Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
- •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.
- •Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
- •Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
- •Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
- •Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
- •Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11
- •Estimated survival of 8 weeks or more following enrollment on the study.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active COVID-19 infection or influenza-like-illness. If subjects have previously tested positive for COVID-19 infection, they are eligible to participate in this study after 90 days
- •Unwilling or unable to follow protocol requirements.
结局指标
主要结局
Adverse Event Collection
时间窗: from date of vaccination until 2 months after full vaccination
次要结局
- Incidence of COVID-19 infection(from date of vaccination until 6 months after full vaccination)
研究者
Utpal P. Davé
Associate Professor Department of Medicine Division of Hematology/Oncology
Indiana University
研究点 (2)
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