A Phase II, Open Label, Multicenter Trial of Venetoclax (ABT-199/GDC-0199) as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell Lymphoma (AITL) and Other Nodal T-cell Lymphomas of T-follicular Helper Origin (TFH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 13
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The FIL_VERT study is a phase II, open label, multicenter clinical trial. The primary of objective of the Study is to evaluate the efficacy of Venetoclax ABT-199/GDC-0199) in terms of overall response rate (ORR) in patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH)
详细描述
This is an open-label, multi-center, single arm phase II trial, with a two-stage design, to evaluate the activity and safety of ABT-199 single agent in patients with BCL-2 pos R/R PTCL-NOS, AITL, TFH.
A pre-screening evaluation of immunohistochemical positivity of BCL-2 will be performed in the relapse biopsy, if available, or otherwise in the initial biopsy. BCL-2 evaluation will be centralized (FIL Laboratories). Only patients with a percentage of BCL-2 positive tumor cells ≥ 25% will be included onto the study. Patients will receive ABT-199 until disease progression, unacceptable toxicity, withdrawal of consent and/or the investigator determines that further therapy is not in the patient's best interest. The primary objective of the study is ORR which will be evaluated after 3 cycles of treatment.
ABT-199 will be administered orally at the dose of 800 mg once daily. Patients will receive ABT-199 until disease progression, unacceptable toxicity, withdrawal of consent and/or the investigator determines that further therapy is not in the patient's best interest (e.g., due to non-compliance, toxicity...) Response evaluation will be performed initially after 3 cycles from the beginning of treatment with ABT-199 (Response Assessment 1) and then every 3 cycles during the first 12 cycles, every 4 cycles from cycle 13 to 24; for those patients still on therapy after 24 cycles, the response evaluation, after this time, will be performed every 6 cycles.
Response will be evaluated according to the Lugano 2014 classification.
TLS is an important identified risk for ABT-199 in oncology studies, especially in CLL. Since there are no available data on the risk of TLS in PTCL, the risk of TLS development should be closely monitored during the study.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARM1 - Venetoclax (ABT-199)
Venetoclax (ABT-199) will be administered orally at the dose of 800 mg once daily.
Response evaluation will be performed initially after 3 cycles from the beginning of treatment with ABT-199 and then every 3 cycles during the first 12 cycles, every 4 cycles from cycle 13 to 24; for those patients still on therapy after 24 cycles, the response evaluation, after this time, will be performed every 6 cycles.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: After the first 3 cycles (each cycle is 28 days)
Overall response rate (ORR) will be defined as the proportion of patient in CR or PR according to Re-sponse Criteria (Lugano 2014) after the first 3 cycles. Efficacy will be assessed after the first 3 cycles or, in case of discontinuation, at the EoT visit. Patients without response assessment (due to whatever reason) will be considered as non-responders.
次要结局
- Partial response (PR)(After the first 3 cycles (each cycle is 28 days))
- Time To Response (TTR)(1 year from the date of the first dose)
- Stable Desease (SD)(After the first 3 cycles (each cycle is 28 days))
- Duration of Remission (DoR)(6 months from the first 3 cycles (each cycle is 28 days))
- Overall Survival (OS)(1 year from the date of the first dose)
- Duration of treatment (DoT)(1 year from the date of the first dose)
- Complete remission (CR)(After the first 3 cycles (each cycle is 28 days))
- Progression free Sruvival (PFS)(1 year from the date of the first dose)
- Toxicity - Incidence of Adverse Events(Through study completion, up to 30 months)