A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 56
- 主要终点
- Overall Response Rate
研究概览
简要总结
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line 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
- •Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008
- •Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing
- •No prior therapy for CLL other than corticosteroids for disease complications
- •CLL that warrants treatment
- •Presence of measurable lymphadenopathy
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
排除标准
- •Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
- •Known presence of myelodysplastic syndrome
- •History of a non-CLL malignancy except for the following:
- •the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or
- •carcinoma in situ of the cervix, or
- •adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
- •asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or
- •ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
- •other adequately treated Stage 1 or 2 cancer currently in complete remission
- •Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- •Ongoing liver injury
- •History of noninfectious pneumonitis
- •Ongoing inflammatory bowel disease
- •History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- •Ongoing immunosuppressive therapy other than corticosteroids
- •Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment
- •Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Idelalisib + rituximab
Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
干预措施: Idelalisib (Drug)
Idelalisib + rituximab
Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
干预措施: Rituximab (Drug)
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. ORR was to be assessed by an independent review committee (IRC).
次要结局
- Duration of Response
- Progression-Free Survival
- Overall Survival
- Nodal Response Rate
- Complete Response Rate
- Minimal Residual Disease Negativity Rate at Week 36