NCT06049134进行中（未招募）4 期
Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
To compare the effects of a pneumococcal vaccine called PCV20 when given as a single dose versus a boosted regimen to patients who previously received anti-CD20 therapy as treatment for B cell lymphoma.
详细描述
Primary Objectives:
--Compare the humoral responses in terms of difference in IgG titers at 1 month from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy.
Secondary Objectives:
- Compare the humoral responses in terms of difference in IgG titers at 3, 6 and12 from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy.
- Estimate the rate of pneumonia (all bacterial pneumonia including pneumococcal pneumonia) within a year from routine single dose PCV20 or a boosted PCV20 regimen in lymphoma survivors who previously received treatment with anti-CD 20 therapy.
- Correlate humoral responses to development of bacterial pneumonia and pneumococcal pneumonia and with severity of this infection in lymphoma survivors within a year of vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year.
- •Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma.
- •Patients who are at least 18 years of age.
- •Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf.
排除标准
- •Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation.
- •Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment.
- •Patients who are unable to attend follow-up appointments at designated times at MD Anderson.
- •Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)
研究组 & 干预措施
Arm Group B (PCV20)
Experimental
Participants will receive 2 doses of the vaccine
干预措施: PCV20 (Biological)
Arm Group A (PCV20)
Experimental
Participants will receive 1 dose of the vaccine
干预措施: PCV20 (Biological)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT05417165Seema Bhat80
已完成
不适用
Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemiaCancerISRCTN21541376Central Manchester and Manchester Children's Hospital (UK)97
进行中（未招募）
1 期
Evaluation of pneumococcal conjugate vaccine (Prevenar) in patients with myeloma and chronic lymphocytic leukaemia - Pneumococcal conjugate vaccination in Haematology patients: Version 1Pneumococcal disease is a common form of meningitis, septicaemia and pneumonia. Those individuals at highest risk include children, the elderly and persons whose immune systems are impaired. This latter group is diverse includes patients with the haematological disorders myeloma and chronic lymphocytic leukaemia in whom infections are a leading cause of death.EUCTR2005-003761-16-GBDepartment of R & D, Central Manchester and Manchester Children's Hospital NHS Trust97
已完成
2 期
Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicNCT00611663Assistance Publique - Hôpitaux de Paris47
已完成
早期 1 期
Immune Response to Pneumococcal Vaccination in Aging HIV Positive AdultsHIV LipodystrophyAgingNCT03039491Medical University of South Carolina160