A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Overall Response Rate
研究概览
简要总结
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
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
- •Histologically confirmed diagnosis of B-cell lymphoma
- •No previous systemic treatment for lymphoma
- •Subject demonstrates need for treatment for lymphoma
- •Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
- •Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
- •Adequate performance status
- •Required baseline laboratory data within protocol-specified parameters
排除标准
- •Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
- •Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- •Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- •Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
- •Ongoing inflammatory bowel disease
- •Known human immunodeficiency virus (HIV) infection
- •History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- •Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Idelalisib + rituximab
Idelalisib + rituximab for up to 104 weeks
干预措施: Idelalisib (Drug)
Idelalisib + rituximab
Idelalisib + rituximab for up to 104 weeks
干预措施: Rituximab (Biological)
结局指标
主要结局
Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
次要结局
- Duration of Response
- Progression-Free Survival
- Idelalisib Trough and Peak Plasma Concentrations(Predose and 1.5 hour postdose at Weeks 2, 4, and 12)
- Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death(Up to 24 weeks plus 30 days)
- Time to Response
- Overall Survival
- Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings(Up to 24 weeks plus 30 days)
- Changes in Health-Related Quality of Life