NCT01650727已完成1 期
A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
研究概览
简要总结
The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
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
- •Must have received at least one prior therapy that includes either
- •fludarabine or equivalent nucleoside analogue or an alternative regimen
- •Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic
- •lymphoma (SLL)
- •Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
- •Women of child-bearing potential who are sexually active, ,including both female subjects and the female sexual partners of male subjects, must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified treatment, and for 12 months after stopping study treatment.
- •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.
- •Life expectancy ≥12 weeks
排除标准
- •Symptomatic brain metastases or primary central nervous system malignancy
- •Treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment
- •Non-hematological toxicities from prior therapy
- •Presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics
- •Known human immunodeficiency virus (HIV) infection or a known HIV-related
- •Clinically active hepatitis B or C defined as disease that requires
- •Women who are breast-feeding, pregnant, or intend to become pregnant
- •Prior allogeneic bone marrow transplant (auto hematopoietic stem cell
- •transplantation [HSCT] is allowed if fully recovered)
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the subject is
- •considered by his or her physician to have a 2 year survival expectation
- •Any investigational drugs within 4 weeks prior to the start of treatment
- •Concurrently receiving treatment in any other clinical study
- •Previously treated with a cyclin dependent kinase (CDK) inhibitor (e.g., dinaciclib or flavopiridol)
- •Active autoimmune anemia or idiopathic thrombocytopenic purpura (ITP) unless
- •stable, defined as being responsive to corticosteroids or other standard therapy
研究组 & 干预措施
Dinaciclib + Rituximab
Experimental
Rituximab will be administered in Cycles 1 and 3-13.
Dinaciclib will be administered in Cycles 2-13.
干预措施: Dinaciclib (Drug)
Dinaciclib + Rituximab
Experimental
Rituximab will be administered in Cycles 1 and 3-13.
Dinaciclib will be administered in Cycles 2-13.
干预措施: Rituximab (Biological)
结局指标
主要结局
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
时间窗: Cycles 2 & 3 (Days 29-84)
次要结局
未报告次要终点
研究者
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