A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).
详细描述
This was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with iNHL whose disease was refractory to rituximab and to either chemotherapy or RIT.
Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles.
After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response [CR] or partial response [PR]) or stable disease according to the International Working Group criteria by the end of Cycle 13.
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
- •Participants who had been diagnosed with iNHL that had progressed.
- •Participants must have exhibited lack of CR or progressive disease (PR) or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
- •Participants must have had rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
- •Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one dimension by computed tomography (CT), positron emission tomography/CT or magnetic resonance imaging.
- •Adequate renal and hepatic function.
排除标准
- •Candidate for potentially curative therapies in the opinion of the investigator.
- •Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.
- •Prior history of allogeneic hematopoietic stem cell transplant.
- •Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
- •Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
- •Symptomatic central nervous system NHL.
- •Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
- •Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core antibodies.
- •History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.
研究组 & 干预措施
Duvelisib
干预措施: Duvelisib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Every 8-16 weeks while on treatment with duvelisib for up to 72 months
ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Every 2-8 weeks for up to 73 months)
- Duration of Response (DOR)(Every 8-16 weeks for up to 72 months)
- Progression-free Survival (PFS)(Every 8-16 weeks for up to 72 months)
- Overall Survival (OS)(Every 16 weeks for up to 72 months)
- Plasma Concentration of Duvelisib and IPI-656(Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit))
- Time to Response (TTR)(First dose to first documentation of complete or partial response (up to 6 months))