Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve the protocol defined change in antibody titers
研究概览
简要总结
This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV20 and PPSV23 are both vaccines that protect against bacteria that cause pneumococcal disease. Giving these vaccinations as series may make a stronger immune response and prevent against pneumococcal infections in patients with chronic lymphocytic leukemia. This is a single-center trial, conducted at Huntsman Cancer Institute.
详细描述
PRIMARY OBJECTIVE:
I. To investigate the proportion of chronic lymphocytic leukemia (CLL) patients who mount an effective immune response to streptococcus pneumonia after receiving both pneumococcal 20-valent conjugate vaccine (PCV20) and pneumococcal polyvalent vaccine (PPSV23) vaccinations. (Primary Analysis)
SECONDARY OBJECTIVES:
I. To improve the immunoglobulin levels and decrease the incidence of pneumonia in patients with CLL-associated immunodeficiency. (Primary Analysis) II. To evaluate the rate of decreased pneumonia as assessed by an immune response to streptococcus (S.) pneumoniae after PCV20 and PPSV23 series versus PCV20 alone. (Primary Analysis) III. To investigate the immune response to individual S. pneumoniae serotypes included in both the PCV20 and PPSV23 vaccinations. (Primary Analysis) IV. Evaluate the length of time an effective immune response is maintained, and if the recommendation of 5 years is adequate for CLL patients. (Primary Analysis)
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
- •NAIVE COHORT: Male or female subject aged >= 18 years.
- •NAIVE COHORT: Subjects must not have received prior therapy for CLL.
- •VENETOCLAX-TREATMENT COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
- •VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =< 12 months prior to registration.
排除标准
- •Subjects who have experienced a severe allergic reaction to prior pneumococcal vaccination.
- •Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the last five years.
- •If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they may be included.
- •Active infection requiring systemic antibiotic therapy.
- •Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:
- •Intranasal, inhaled, topical steroids, eye drops or local steroid injection (e.g., intra-articular injection);
- •Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent;
- •Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
- •Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.
研究组 & 干预措施
Arm I (PCV20, PPSV23)
Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)
干预措施: Questionnaire Administration (Other)
Arm II (PCV20, PPPSV23)
Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity.
干预措施: Pneumococcal Polyvalent Vaccine (Biological)
Arm II (PCV20, PPPSV23)
Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm I (PCV20, PPSV23)
Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)
干预措施: Pneumococcal Polyvalent Vaccine (Biological)
Arm I (PCV20, PPSV23)
Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)
干预措施: Pneumococcal 20-valent Conjugate Vaccine (Biological)
Arm II (PCV20, PPPSV23)
Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity.
干预措施: Pneumococcal 20-valent Conjugate Vaccine (Biological)
结局指标
主要结局
Proportion of patients who achieve the protocol defined change in antibody titers
时间窗: At 30 and 90 days post-PCV20 vaccination
Will examine the proportion of patients who achieve the protocol defined change in antibody titers from baseline in at least 10 of 19 S.pneumoniae serotypes shared between pneumococcal 20-valent conjugate vaccine (PCV20) and pneumococcal polyvalent vaccine (PPSV23) at Study Visit 2 and 3. The observed proportion and an exact 95% binomial confidence interval will be reported. A one sample exact binomial test will be performed at one-sided alpha = 0.05. The null hypothesis is that the proportion is 50% or lower.
次要结局
- Proportion of patients who have a two-fold increase in antibody titers to an individual serotype vaccination(At 30 and 90 days post-PCV20 vaccination)
- Proportion of patients who maintain adequate immune response(Up to 5 years post PPSV23 vaccination)
- Proportion of patients who have a two-fold increase of immunoglobulin levels(Up to 5 years post- PPSV23 vaccination)
- Proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines(Up to 5 years post PPSV23 vaccination)