A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
研究概览
简要总结
Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients with Waldenstrom's Macroglobulinemia (WM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.
- •Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.
- •Adequate organ function.
- •Detectable CD20 positive of the tumor cells.
- •Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL.
排除标准
- •Treatment of WM within the past 28 days.
- •Treatment with rituximab or alemtuzamab within the past 3 months.
- •Certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years.
- •Current participation in another interventional clinical study.
- •Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception.
- •Active cerebrovascular disease.
结局指标
主要结局
Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
时间窗: Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator
时间窗: Baseline and up to Study Week 16
OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
次要结局
- Clearance of Ofatumumab(From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7)
- Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator(Baseline and up to Study Week 16)
- Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)(Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment)
- Progression-free Survival(From baseline up to approximately 5 years)
- Time to Response for Responders(From baseline up to approximately 5 years)
- Overall Survival(From baseline up to approximately 5 years)
- Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result(From baseline up to approximately 5 years)
- Number of Participants With the Indicated SAEs Related to Study Drug(From baseline up to approximately 5 years)
- Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Drug and Withdrawal From Study(From baseline up to approximately 5 years)
- Number of Participants With the Indicated >=Grade 3 AEs(From baseline up to approximately 5 years)
- Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator(Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment)
- Cmax and Ctrough of Ofatumumab(From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7)
- AUC(0-tau) and AUC(0-inf) of Ofatumumab(From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7)
- Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator(From baseline up to approximately 5 years)
- Volume of Distribution at Steady State of Ofatumumab(From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7)
- Half-life of Ofatumumab(From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7)
- Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment(Baseline and Month 3)
- Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug(From baseline up to approximately 5 years)
- Number of Participants With the Indicated Infusion-related >=Grade 3 AE(From baseline up to approximately 5 years)