A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 85
- 主要终点
- Objective Response Rate (ORR) Based on Lugano Classification Criteria
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with 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 or older (except in South Korea, aged 19 or older).
- •Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
- •Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
- •Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
- •Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- •Eastern Cooperative Oncology Group performance status 0 to 2.
排除标准
- •Evidence of diffuse large B-cell transformation.
- •History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- •Prior treatment with idelalisib, other selective 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 the first dose of study treatment.
- •Active graft versus host disease.
- •Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
研究组 & 干预措施
Cohort 1- Closed to Further enrollment
Participants who have received prior ibrutinib.
干预措施: Parsaclisib (Drug)
Cohort 2
Participants who have not received a prior BTK inhibitor.
干预措施: Parsaclisib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Based on Lugano Classification Criteria
时间窗: Up to approximately 161 weeks
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),assign 5mm×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 1305 days)
- Complete Response Rate (CRR) Based on Lugano Classification Criteria(Up to 1305 days)
- Progression-Free Survival (PFS)(Up to 1305 days)
- Overall Survival (OS)(Up to 2354 days)
- Best Percent Change From Baseline in Target Lesion Size(Up to 1305 days)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From first dose of study drug up to 1980 days)