Carfilzomib (K) Plus Lenalidomide (R) and Dexamethasone (D) for BTK Inhibitors Relapsed-refractory or Intolerant Mantle Cell Lymphomas: a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 11
- 主要终点
- Primary Efficacy Endpoint - 12-months overall survival
研究概览
简要总结
This is a prospective, multicenter, single arm, phase II trial designed to evaluate activity and the safety of the combination of Carfilzomib (K), Lenalidomide (R) and Dexamethasone (D) in patients with mantle cell lymphoma (MCL) relapsed/refractory (R/R) or intolerant to BTK inhibitor (BTKi) monotherapy or BTKi containing regimens with active disease necessitating treatment.
详细描述
This is a prospective, multicenter, single arm, phase II trial designed to evaluate the safety and efficacy of the combination of Carfilzomib (K), Lenalidomide (R) and Dexamethasone (D) in patients with mantle cell lymphoma (MCL) relapsed/refractory (R/R) or intolerant to BTK inhibitor (BTKi) monotherapy or BTKi containing regimens.
The primary endpoint will be assessed 12 months after the start of treatment of the last patient. However, responsive patients (CR, PR, SD) may continue to receive K up to a maximum of 24 cycles and RD up to a maximum of 24 cycles. Patients who will interrupt therapy (for any reason) will be followed up to 12 months after the end of the treatment.
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 80 Years（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
Carfilzomib (K) plus Lenalidomide (R) and Dexamethasone (D)
Carfilzomib (K) (maximum period of treatment= 24 cycles)
- K on days 1-2, 8-9, 15-16 during cycles 1-12. The dosage of K will be 20 mg/m2 10' iv infusion on day 1 and 2 during cycle 1 and then 27 mg/m2 10' iv infusion thereafter;
- K: on days 1-2, 15-16 during cycles 13-24. The dosage of K will be 27 mg/m2 10' iv infusion. Lenalidomide (R) (maximum period of treatment= 24 cycles)
- R: 25 mg/daily on day 1 to 21 of a 28 days course; for patients with creatinine clearance ≥ 30 mL/min but < 50 mL/min the dosage of R will be 10 mg/daily on day 1 to 21 of a 28 days course.
Dexamethasone (D) (maximum period of treatment= 24 cycles) PO or IV D on days 1-2, 8-9, 15-16, 22-23. The dosage will be 20 mg between 30 minutes and 4 hours prior to K. For patients older than 75 years the dosage may be reduced at 10 mg.
干预措施: Carfilzomib (Drug)
Carfilzomib (K) plus Lenalidomide (R) and Dexamethasone (D)
Carfilzomib (K) (maximum period of treatment= 24 cycles)
- K on days 1-2, 8-9, 15-16 during cycles 1-12. The dosage of K will be 20 mg/m2 10' iv infusion on day 1 and 2 during cycle 1 and then 27 mg/m2 10' iv infusion thereafter;
- K: on days 1-2, 15-16 during cycles 13-24. The dosage of K will be 27 mg/m2 10' iv infusion. Lenalidomide (R) (maximum period of treatment= 24 cycles)
- R: 25 mg/daily on day 1 to 21 of a 28 days course; for patients with creatinine clearance ≥ 30 mL/min but < 50 mL/min the dosage of R will be 10 mg/daily on day 1 to 21 of a 28 days course.
Dexamethasone (D) (maximum period of treatment= 24 cycles) PO or IV D on days 1-2, 8-9, 15-16, 22-23. The dosage will be 20 mg between 30 minutes and 4 hours prior to K. For patients older than 75 years the dosage may be reduced at 10 mg.
干预措施: Lenalidomide (Drug)
Carfilzomib (K) plus Lenalidomide (R) and Dexamethasone (D)
Carfilzomib (K) (maximum period of treatment= 24 cycles)
- K on days 1-2, 8-9, 15-16 during cycles 1-12. The dosage of K will be 20 mg/m2 10' iv infusion on day 1 and 2 during cycle 1 and then 27 mg/m2 10' iv infusion thereafter;
- K: on days 1-2, 15-16 during cycles 13-24. The dosage of K will be 27 mg/m2 10' iv infusion. Lenalidomide (R) (maximum period of treatment= 24 cycles)
- R: 25 mg/daily on day 1 to 21 of a 28 days course; for patients with creatinine clearance ≥ 30 mL/min but < 50 mL/min the dosage of R will be 10 mg/daily on day 1 to 21 of a 28 days course.
Dexamethasone (D) (maximum period of treatment= 24 cycles) PO or IV D on days 1-2, 8-9, 15-16, 22-23. The dosage will be 20 mg between 30 minutes and 4 hours prior to K. For patients older than 75 years the dosage may be reduced at 10 mg.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Primary Efficacy Endpoint - 12-months overall survival
时间窗: The primary endpoint will be assessed 12 months after the start of treatment of the last patient.
12-month overall survival : probability of surviving from the date of beginning of therapy up to month 12 based on Kaplan-Meier estimator
次要结局
- Secondary Endpoints 1 - ORR(The endpoint will be assessed from the date of randomization to the date of the first documented progression, evaluated up to 12 months.)
- Secondary Endpoints 4 - TTR(through the completion of the study, an average of 1 year)
- Secondary Endpoints 5 - DoT(through the completion of the study, an average of 1 year)
- Secondary Endpoints 1 - CR(The endpoint will be assessed from the date of randomization to the date of the first documented progression, evaluated up to 12 months.)
- Secondary Endpoints 1 - SD(The endpoint will be assessed from the date of randomization to the date of the first documented progression, evaluated up to 12 months.)
- Secondary Endpoints 3 - OS(through the completion of the study, an average of 1 year)
- Secondary Endpoints 1 - PR(The endpoint will be assessed from the date of randomization to the date of the first documented progression, evaluated up to 12 months.)
- Secondary Endpoints 2 - PFS(The endpoint will be assessed from the date of randomization to the date of the first documented progression, evaluated up to 12 months.)