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临床试验/NCT03900377
NCT03900377已完成1 期

A Multicenter, Open-label, Phase I/II Study to Investigate the Safety and Tolerability of SyB L-0501RI (Bendamustine Hydrochloride for Injection) Administered As an Intravenous (IV) Rapid Infusion Over 10 Minutes

SymBio Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
37
试验地点
1
主要终点
Number of adverse events

研究概览

简要总结

For SyB L-0501RI administered by an intravenous rapid infusion in combination with rituximab, the safety will be investigated in previously untreated patients with low-grade B-cell non-Hodgkin's lymphoma (Lg-B-NHL) or mantle cell lymphoma (MCL), and the safety and tolerability will be investigated in patients with recurrent/refractory diffuse large B-cell lymphoma (DLBCL).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Lg-B-NHL or MCL

Experimental

For previously untreated patients with Lg-B-NHL or MCL, rituximab will be intravenously administered at 375 mg/m^2 on Day 0 (the day before Day 1 only in Cycle 1), and SyB L-0501RI will be intravenously administered at 90 mg/m^2/day on Day 1 and Day 2 of each 28-day cycle with up to 6 cycles.

干预措施: SyB L-0501RI (Drug)

DLBCL

Experimental

For patients with recurrent or refractory DLBCL, rituximab will be intravenously administered at 375 mg/m^2 on Day 1, and SyB L-0501RI will be intravenously administered at 120 mg/m^2/day on Day 2 and Day 3 of each 21-day cycle with up to 6 cycles.

干预措施: SyB L-0501RI (Drug)

结局指标

主要结局

Number of adverse events

时间窗: Up to 36 weeks

Number of subjects with abnormality (Common Terminology Criteria for Adverse Events [CTCAE] grade ≥3) in laboratory test values

时间窗: Up to 36 weeks

Number of subjects with grade ≥3 physical examination finding

时间窗: Up to 36 weeks

Adverse events (type, frequency, severity)

时间窗: Up to 36 weeks

Number of subjects with dose limiting toxicity in DLBCL arm

时间窗: Up to 36 weeks

Number of subjects with adverse event

时间窗: Up to 36 weeks

次要结局

  • Progression-free survival (PFS)(Up to 36 weeks)
  • The half-life period (T1/2) of unchanged SyB L-0501(Prior to and 5, 10 min after start of administration, and 5, 15, 30, 60, 120, 240, 360 min after completion of administration on Day 1 of the 1st cycle in Lg-B-NHL or MCL Arm (in DLBCL Arm, Day 2 of the 1st cycle))
  • Overall response rate (antitumor effect : ≥ partial response [PR])(Up to 36 weeks)
  • The maximum concentration (Cmax) of unchanged SyB L-0501(Prior to and 5, 10 min after start of administration, and 5, 15, 30, 60, 120, 240, 360 min after completion of administration on Day 1 of the 1st cycle in Lg-B-NHL or MCL Arm (in DLBCL Arm, Day 2 of the 1st cycle))
  • Complete response (CR) rate(Up to 36 weeks)
  • The area under the curve (AUC) for unchanged SyB L-0501(Prior to and 5, 10 min after start of administration, and 5, 15, 30, 60, 120, 240, 360 min after completion of administration on Day 1 of the 1st cycle in Lg-B-NHL or MCL Arm (in DLBCL Arm, Day 2 of the 1st cycle))
  • The maximum drug concentration time (Tmax) of unchanged SyB L-0501(Prior to and 5, 10 min after start of administration, and 5, 15, 30, 60, 120, 240, 360 min after completion of administration on Day 1 of the 1st cycle in Lg-B-NHL or MCL Arm (in DLBCL Arm, Day 2 of the 1st cycle))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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