NCT02292225终止1 期
A Phase 1b Study of Duvelisib Administered in Combination With Obinutuzumab in Patients With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) (SYNCHRONY)
SecuraBio0 个研究点目标入组 3 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 主要终点
- Dose-limiting toxicities (DLTs)
研究概览
简要总结
To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.
详细描述
This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.
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
- •≥18 years of age
- •Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for treatment (Binet Stage ≥ B and/or Rai Stage ≥ I with symptoms)
- •Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)
- •Previous exposure to BTKi therapy and meets at least one of the below criteria:
- •Progressive disease while receiving a BTKi therapy, or stable disease as best response after 12 months of receiving a BTKi therapy
- •Discontinued a BTKi therapy due to BTKi treatment-related intolerance
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status [KPS] ≥60%)
- •Subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period
排除标准
- •Richter's transformation or prolymphocytic leukemia
- •Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
- •Progressive disease while previously receiving a PI3K inhibitor (e.g. GS-1101 [idelalisib], duvelisib) or a serious/severe AE related to PI3K inhibitor treatment
- •History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)
- •Human immunodeficiency virus (HIV) or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
- •Prior, current, or chronic hepatitis B or hepatitis C infection
- •History of tuberculosis treatment within the preceding 2 years
研究组 & 干预措施
IPI-145 in Combination with Obinutuzumab
Experimental
干预措施: IPI-145 (duvelisib) (Drug)
IPI-145 in Combination with Obinutuzumab
Experimental
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs)
时间窗: 28 days
Treatment-emergent adverse events (TEAEs)
时间窗: Up to 30 days from last dose of study treatment
次要结局
- Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite)(Week 1, Week 2, Months 2, 4, 7, 11, 15, 19)
- Overall survival (OS)(Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later)
- BTK mutation status(Baseline)
- Duration of response (DOR)(Up to 2 years from the first dose of study treatment)
- Progression-free survival (PFS)(Up to 2 years from the first dose of study treatment)
- Overall response rate (ORR)(Up to 2 years from the first dose of study treatment)
研究者
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