NCT01580228已完成3 期
A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Participant Progression Free Survival
研究概览
简要总结
This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.
详细描述
Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Aged 18 years or older
- •Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
- •Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2
- •Adequate organ function and laboratory parameters
- •Women of child-bearing potential who are not currently sexually active must
- •agree to use a medically accepted method of contraception should they become
- •sexually active while participating in the study
排除标准
- •Symptomatic brain metastases or primary central nervous system malignancy
- •Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization
- •Known human immunodeficiency virus (HIV) infection or a known HIV-related
- •Participants with with clinically active hepatitis B or C defined as disease that requires therapy
- •Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency
- •Prior allogeneic bone marrow transplant
- •Presence of Richter's transformation
- •Indeterminate deletion 17p status
- •Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors
- •Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy
研究组 & 干预措施
Dinaciclib
Experimental
干预措施: Dinaciclib (Drug)
Ofatumumab
Active Comparator
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Participant Progression Free Survival
时间窗: From date of randomization up to approximately 38 months
次要结局
- Participant Overall Response Rate(From date of randomization up to approximately 38 months)
- Participant Overall Survival Rate(From date of randomization until up to approximately 50 months)
研究者
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