An Open-label Phase II Study of BKM120 in Subjects With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS)
研究概览
简要总结
This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
- •Patient had relapsed or refractory disease and received at least one prior therapy.
- •Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.
- •Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have had at least one measurable extra-nodal lesion.
- •Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patient had adequate bone marrow and organ function.
排除标准
- •Patient had received previous treatment with PI3K inhibitors
- •Patient had evidence of graft versus host disease (GVHD).
- •Patient had active or history of central nervous system (CNS) disease.
- •Patient had a concurrent malignancy or had a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
- •Patient had a score ≥ 12 on the PHQ-9 questionnaire.
- •Patient had a GAD-7 mood scale score ≥
- •Pregnant or nursing women
- •Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.
研究组 & 干预措施
DLBCL Cohort
Diffuse large B-cell lymphoma cohort
干预措施: Buparlisib (Drug)
MCL Cohort
Mantle cell lymphoma cohort
干预措施: Buparlisib (Drug)
FL Cohort
Follicular lymphoma cohort
干预措施: Buparlisib (Drug)
结局指标
主要结局
Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS)
时间窗: Baseline up to 6 months
Overall Response rate is the percentage of patients in a cohort who experienced either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total percentage of patients included in the corresponding cohort according to Cheson criteria The analysis for each cohort was based on an exact binomial test comparing the ORR to the reference level of 10% (null hypothesis) in the FAS. The test for each cohort used a significance level of 5%. The ORR was presented together with an exact 95% Clopper- Pearson confidence interval. Disease Control Rate (DCR progressive. Disease Control Rate (DCR) was the percentage of patients with CR, PR or SD (stable disease). Patients for whom the best response after treatment start was missing, unknown (UNK) or progressive disease (PD) were considered non-responders and were counted in the denominator for the estimation of the ORR
次要结局
- Progression- Free Survival (PFS) Based on Investigator Assessment (FAS)(Baseline up to approximately 44 months)
- Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS)(Baseline up to approximately 18 months)
- Overall Survival (OS) - Percentage of Participants With OS Events (FAS)(Baseline up to approximately 44 months)
- Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS)(Baseline up to approximately 18 months)
- Overall Survival - Median (FAS)(Baseline up approximately 44 months)