NCT00349349已完成2 期
A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines
研究概览
简要总结
The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.
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
- •Tumor cell phenotype consistent with B-CLL
- •Patients with active B-CLL and with an indication for treatment
- •Failing at least one fludarabine-containing treatment regimen
- •Failing at least one alemtuzumab-containing treatment regimen
- •ECOG Performance Status of 0, 1, or 2
- •Life expectancy of at least 4 months
排除标准
- •Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
- •Previous autologous stem cell transplantation within 6 months prior to Visit 2
- •Allogeneic stem cell transplantation
- •Radioimmunotherapy
研究组 & 干预措施
ofatumumab
Experimental
Anti-CD20 antibody therapy
干预措施: ofatumumab (Drug)
结局指标
主要结局
Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines
时间窗: Start of treatment (Week 0 of Visit 2) until Week 24
Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) were classified as responders, while those with stable disease (SD) and progressive disease (PD) were classified as non-responders. Per the NCIWG guideline (1996): CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, bone marrow sample as normocellular for age, \<30% lymphocytes (LC), no lymphoid nodule; PR: a \>=50% decrease in LC/lymphadenopathy; nPR: persistent nodules in bone marrow; PD: new lesion or increase by \>=50% from baseline; SD: no CR, PR, or PD.
次要结局
- Duration of Response(Start of treatment (Week 0 of Visit 2) until Week 24)
- Progression-Free Survival (PFS)(Start of treatment (Week 0 of Visit 2) until Week 24)
- Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment(Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months]))
- Overall Survival(Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks))
- Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts(Baseline (Visit 2) until Week 7 (Visit 9))
- Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts(Baseline (Visit 2) until Week 7 (Visit 9))
- Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)(Baseline (Visit 2) until Week 24 (Visit 14))
- Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24(Baseline (Visit 2) and Week 24)
- Number of Participants With Complete Resolution of Lymphadenopathy(Baseline (Visit 2) to end of study (up to Week 24))
- Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24(Baseline (Visit 2) and Week 24)
- Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening(Screening (Visit 1, <=14 days prior to Visit 2))
- Number of Participants With Improvement in Hemoglobin(Baseline (Visit 2) to Week 28)
- Number of Participants With Improvement in Thrombocytopenia (Thromb.)(Baseline (Visit 2) to Week 28)
- Number of Participants With Complete Resolution of Hepatomegaly(Baseline (Visit 2) until Week 24)
- Number of Participants With Improvement in Neutropenia(Baseline (Visit 2) to Week 28)
- Number of Participants With Complete Resolution of Splenomegaly(Baseline (Visit 2) until Week 24)
- Number of Participants Who Experienced Any Adverse Event(From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up))
- Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)(Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24))
- AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit 14 (Week 24))
- Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit14 (Week 24))
- Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit 14 (Week 24))
- Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit 14 (Week 24))
研究者
相似试验
已完成
2 期
HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to RituximabLymphoma, FollicularNCT00394836GlaxoSmithKline116
撤回
1 期
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular LymphomaLymphoma, FollicularNCT00092274GlaxoSmithKline
撤回
1 期
HuMax-CD20 in Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT00093314GlaxoSmithKline
已完成
4 期
Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)Leukaemia, Lymphocytic, ChronicNCT00802737GlaxoSmithKline29
招募中
4 期
Anti-CD20 Antibodies for Treatment of SLE-PAHSystemic Lupus ErythematosusPulmonary Arterial HypertensionNCT05828147Chinese SLE Treatment And Research Group50