A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 103
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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.
- •Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
- •Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
排除标准
- •History of central nervous system lymphoma (either primary or metastatic).
- •Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan PI3K inhibitor.
- •Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.
- •Active graft-versus-host disease.
- •Liver disease: Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).
研究组 & 干预措施
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks.
Participants who were exposed to ibrutinib before enrollment were included in this group.
干预措施: Parsaclisib (Drug)
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks.
Participants who were exposed to ibrutinib before enrollment were included in this group.
干预措施: Parsaclisib (Drug)
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks.
Participants who had not received a BTK inhibitor previously were included in this group.
干预措施: Parsaclisib (Drug)
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks.
Participants who had not received a BTK inhibitor previously were included in this group.
干预措施: Parsaclisib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 1016 days
ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node\>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by\>50%in length beyond normal.4.No new lesions.
次要结局
- Duration of Response (DOR)(Up to 1016 days)
- Complete Response Rate (CRR)(Up to 1016 days)
- Progression-Free Survival (PFS)(Up to 1016 days)
- Overall Survival (OS)(Up to 2017 days)
- Best Percent Change From Baseline in Target Lesion Size(Up to 1016 days)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From first dose of study drug up to 2045 days)