A Two Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Rituximab Subcutaneous (SC) Formulation in Patients With Follicular Lymphoma (FL) as Part of Maintenance Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 281
- 主要终点
- Minimum Observed Plasma Trough Concentration (C trough)
研究概览
简要总结
This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625 mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •CD20-positive follicular non-Hodgkin's lymphoma (NHL)
- •Documented partial or complete response a the end of induction treatment with rituximab
- •Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (<=) 2
- •Life expectancy of greater than and equal to (>=) 6 months
排除标准
- •Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma
- •Presence or history of central nervous system disease
- •History of malignancy other than follicular NHL
- •Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy
研究组 & 干预措施
Rituximab IV 375 mg/m^2 (Stage 1: Cohort A)
干预措施: Rituximab (Drug)
Rituximab IV 375 mg/m^2 (Stage 2: Cohort E)
干预措施: Rituximab (Drug)
Rituximab SC 1400 mg (Stage 2: Cohort F)
干预措施: Rituximab (Drug)
Rituximab SC 375 mg/m^2 (Stage 1: Cohort B)
干预措施: Rituximab (Drug)
Rituximab SC 625 mg/m^2 (Stage 1: Cohort C)
干预措施: Rituximab (Drug)
Rituximab SC 800 mg/m^2 (Stage 1: Cohort D)
干预措施: Rituximab (Drug)
结局指标
主要结局
Minimum Observed Plasma Trough Concentration (C trough)
时间窗: Up to 29 months
次要结局
- Plasma Decay Half-Life (t1/2)(Up to 29 months)
- Maximum Observed Plasma Concentration (Cmax)(Up to 29 months)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Up to 29 months)
- Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)(Up to 29 months)
- Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)(Up to 29 months)
