NCT03424122已完成1 期
A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
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
- 50
- 试验地点
- 21
- 主要终点
- Number of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Men and women, aged 18 years or older on the day of signing the Informed Consent Form (ICF).
- •Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.
- •Participants with DLBCL, MZL or MCL must have received at least 1 prior line of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
- •Participants with FL must have received at least 2 prior lines of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
- •Ineligible for stem cell transplant.
- •Participants with DLBCL must have failed or refused stem cell transplantation or failed first-line salvage therapy if ineligible for transplantation.
- •Must be willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
- •Life expectancy of > 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 (see Appendix D).
- •Willingness to avoid pregnancy or fathering a child.
- •Ability to comprehend and willingness to sign an ICF
排除标准
- •Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
- •Histologically confirmed rare non-Hodgkin B-cell subtypes.
- •History of or central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- •Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- •For participants to be treated with bendamustine (Treatment B), prior treatment with bendamustine (within 12 months of the start of study treatment). Participants 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 response (PR) or complete response (CR) to the bendamustine regimen of at least 12 months in duration before relapse/progression.
- •Experienced progression following a regimen containing an alkylating agent.
- •For participants to be treated with ibrutinib (Treatment C), prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
- •Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- •Active graft-versus-host disease following allogeneic transplant.
- •Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
研究组 & 干预措施
Treatment A
Experimental
Parsaclisib + Rituximab
干预措施: Parsaclisib (Drug)
Treatment A
Experimental
Parsaclisib + Rituximab
干预措施: Rituximab (Drug)
Treatment B
Experimental
Parsaclisib + Bendamustine + Rituximab
干预措施: Parsaclisib (Drug)
Treatment B
Experimental
Parsaclisib + Bendamustine + Rituximab
干预措施: Rituximab (Drug)
Treatment B
Experimental
Parsaclisib + Bendamustine + Rituximab
干预措施: Bendamustine (Drug)
Treatment C
Experimental
Parsaclisib + Ibrutinib
干预措施: Parsaclisib (Drug)
Treatment C
Experimental
Parsaclisib + Ibrutinib
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events (TEAEs)
时间窗: Up to approximately 12 months.
A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
次要结局
- Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib(Up to approximately 1 month.)
- Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib(Up to approximately 1 month.)
研究者
研究点 (21)
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