NCT00802737已完成4 期
A Single-arm, International, Multi-center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance in CLL Patients Who Progressed Following Response or Stable Disease After Ofatumumab Treatment in Hx-CD20-406
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines
研究概览
简要总结
The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Has responded to ofatumumab treatment (CR, nPR, PR) or has had SD at least up to and including visit number 14 (24 weeks after first infusion) in the Hx-CD20-406 trial.
- •Has disease progression after visit number 14 (24 weeks after first infusion) in the Hx CD20 406 trial.
- •Received at least eight ofatumumab infusions.
- •Has active CLL with an indication for treatment.
- •Has Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1 or
- •Provides signed informed consent, following receipt of verbal and written information about the trial, before any trial related activity is carried out.
- •If previously treated in GEN416 (this trial), the patient must have achieved CR with subsequent disease progression 24 weeks or later after the first infusion in the GEN416 trial.
排除标准
- •The disease has transformed to more aggressive B-cell malignancies (e.g. diffuse large B-cell lymphoma, Richter's syndrome or prolymphocytic leukemia).
- •Has a suspected treatment requiring malignancy other than CLL.
- •Has received treatment other than ofatumumab within two weeks prior to visit
- •Has clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from visit 1, congestive heart failure (NYHA III IV), and arrhythmia requiring therapy, with the exception of clinically non-significant extra systoles or minor conduction abnormalities.
- •Has significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
- •Has a history of significant cerebrovascular disease.
- •Is known HIV positive.
- •Has positive serology for hepatitis B, defined as a positive test for HBsAg and/or positive tests for both anti-HBs and anti-HBc.
- •Has known or suspected hypersensitivity to components of the IMP.
- •Has received treatment with any non-marketed drug substance or experimental therapy other than ofatumumab within four weeks prior to visit
- •Currently participates in any other interventional clinical trial other than Hx-CD20-
- •Known or suspected to not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychiatric disorder).
- •Is breast feeding (women only).
- •Has a positive pregnancy test at screening (women only).
- •Is not willing to use adequate contraception during the trial and one year after last dose of ofatumumab (women only). Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the US the use of double barrier method is considered adequate.
研究组 & 干预措施
Ofatumumab
Experimental
Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines
时间窗: Start of treatment (Week 0/Visit 2) until Week 52
Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits \>=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, \<30% lymphocytes (LC), no lymphoid nodule; PR: \>=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by \>=50% from baseline; SD: no CR, PR, or PD.
次要结局
- Progression-Free Survival (PFS)(Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months))
- Overall Survival (OS)(Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months))
- Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment(Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months))
- Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 12(Baseline (Visit 2) and Month 12)
- Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 24(Baseline (Visit 2) and Month 24)
- Duration of Response(From the time of the initial response until progression or death (average of 14.1 study months))
- Number of Participants With the Indicated Major Infections(From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34]))
- Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4(Baseline (Visit 2) and Month 4)
- Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of Screening and Post Ofatumumab(Screening and post ofatumumab (up to Study Month 32))
- Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics(From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34]))
- Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4)(Visit 2 (Week 0) and Visit 14 (Month 4))
- Number of Participants Who Experienced Any Adverse Event(From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34]))
研究者
研究点 (1)
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