NCT03039114已完成1 期
An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma (CITADEL-102)
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
- 26
- 试验地点
- 21
- 主要终点
- Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).
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
- •Histologically confirmed FL.
- •Documented CD20+ FL.
- •Relapsed or refractory to any prior rituximab-containing regimen.
- •Previously treated with a maximum of 4 cancer-directed treatment regimens.
- •At least 1 measurable lesion > 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging.
- •Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
排除标准
- •Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
- •History of central nervous system lymphoma (either primary or metastatic).
- •Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
- •Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- •Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor.
- •Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria:
- •Did not discontinue because of tolerability concerns.
- •Achieved either partial or CR to the bendamustine regimen of at least 12 months in duration before relapse/progression.
- •Experienced progression following a regimen containing an alkylating agent.
- •Received prior obinutuzumab.
- •Received rituximab within 4 weeks of study start.
- •Prior treatment-related toxicities that have not resolved to ≤ Grade 1 before the date of study drug administration except for stable chronic toxicities (≤ Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
- •Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).
研究组 & 干预措施
Parsaclisib + Hexal and Gazyvaro
Experimental
干预措施: Hexal (Drug)
Parsaclisib + Hexal and Gazyvaro
Experimental
干预措施: Parsaclisib (Drug)
Parsaclisib + Hexal and Gazyvaro
Experimental
干预措施: Gazyvaro (Drug)
结局指标
主要结局
Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)
时间窗: Screening through 30-35 days after end of treatment, up to approximately 34 months per subject
次要结局
- Objective response rate based on Lugano classification criteria(Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject)
- Complete response rate based on Lugano classification criteria(Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject)
- Progression-free survival(Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject)
- Duration of response(Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject)
- Overall survival(From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject)
研究者
研究点 (21)
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