A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 83
- 主要终点
- Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
研究概览
简要总结
The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.
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
- •Aged 18 years or older.
- •Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.
- •Ineligible for hematopoietic stem cell transplant.
- •Must have been treated with at least 2 prior systemic therapies.
- •Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
- •Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
排除标准
- •Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
- •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.
- •Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- •Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
- •Active graft-versus-host 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
Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW
Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.
干预措施: Parsaclisib (Drug)
Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
干预措施: Parsaclisib (Drug)
结局指标
主要结局
Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
时间窗: Up to approximately 148 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),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
- Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria(Up to 1193 days)
- Duration of Response (DOR)(Up to 1193 days)
- Progression-free Survival (PFS) With Parsaclisib(Up to 1193 days)
- Overall Survival (OS) With Parsaclisib(Up to 1193 days)
- Best Percent Change From Baseline in Target Lesion Size(Up to 1193 days)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(up to approximately 1992 days)