A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Progression Free Survival (PFS) in R/R FL and MZL participants
研究概览
简要总结
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (MZL or FL) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double blinded
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
- •Male and female participants aged 18 years or older (Japan, aged 20 years or older).
- •Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
- •Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)
- •Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb
- •Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
- •ECOG PS of 0 to 2
- •Adequate organ functions including hematopoiesis, liver, and kidney
- •Willingness to avoid pregnancy or fathering children
排除标准
- •Women who are pregnant or breastfeeding.
- •Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma).
- •Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
- •Prior treatment with PI3K inhibitors.
- •Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs.
- •Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease.
- •Known HIV infection.
- •HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA.
- •History of other malignancy within 2 years of study entry.
- •Any condition that would, in the investigator's judgment, interfere with full participation in the study.
研究组 & 干预措施
Treatment Group A
Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
干预措施: parsaclisib (Drug)
Treatment Group A
Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
干预措施: rituximab (Drug)
Treatment Group A
Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
干预措施: obinutuzumab (Drug)
Treatment Group B
Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab
干预措施: rituximab (Drug)
Treatment Group B
Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab
干预措施: obinutuzumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) in R/R FL and MZL participants
时间窗: 62 months
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(10 years)
- Progression Free Survival (PFS) in R/R MZL participants(62 months)
- Complete Response Rate (CRR)(62 months)
- Event Free Survival (EFS)(62 months)
- Time To Next antiLymphoma Therapy (TTNLT)(62 months)
- Progression-Free Survival on next antilymphoma therapy (PFS2)(62 months)
- Number of Treatment Emergent Adverse Events (TEAE's)(62 months)
- Progression Free Survival (PFS) in R/R FL participants(62 months)
- Overall Response Rate (ORR)(62 months)
- Duration of Response (DOR)(62 months)
- Disease Control Rate (DCR)(62 months)