A Pilot Trial of Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With DLBCL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Feasibility and tolerability of blinatumomab consolidation post auto-SCT as measured by percentage of patients who can finish a full course of blinatumomab post-auto-SCT
研究概览
简要总结
Based on the further need to improve progression-free survival (PFS) and overall survival (OS) post autologous stem cell transplant (SCT) for DLBCL, the hematopoietic profile of patients following auto-SCT, the activity of blinatumomab in DLBCL and its favorable toxicity profile, the investigators propose a pilot study to test blinatumomab as consolidation therapy post auto-SCT for patients with DLBCL.
The investigators hypothesize the blinatumomab consolidation will optimize the effector to target (E-T) ratio and aid in the eradication of remaining tumor cells, leading to decreased relapse and increased overall survival. In addition, since tumor burden will be at a minimum, infusional toxicities including neurologic toxicities may also be limited. The purpose of this pilot study is to study the feasibility and tolerability of blinatumomab consolidation post auto-SCT for patients with chemo-sensitive DLBCL undergoing auto-SCT.
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
ASCT + BEAM + Blinatumomab
-
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed:
-
carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7
-
etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses)
-
cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses)
-
melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2
-
Auto-SCT will take place on Day 0 as per institutional guidelines
-
Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
干预措施: Blinatumomab (Drug)
ASCT + BEAM + Blinatumomab
-
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed:
-
carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7
-
etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses)
-
cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses)
-
melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2
-
Auto-SCT will take place on Day 0 as per institutional guidelines
-
Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
干预措施: Autologous stem cell transplant (Procedure)
ASCT + BEAM + Blinatumomab
-
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed:
-
carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7
-
etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses)
-
cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses)
-
melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2
-
Auto-SCT will take place on Day 0 as per institutional guidelines
-
Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
干预措施: Carmustine (Drug)
ASCT + BEAM + Blinatumomab
-
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed:
-
carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7
-
etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses)
-
cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses)
-
melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2
-
Auto-SCT will take place on Day 0 as per institutional guidelines
-
Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
干预措施: Etoposide (Drug)
ASCT + BEAM + Blinatumomab
-
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed:
-
carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7
-
etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses)
-
cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses)
-
melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2
-
Auto-SCT will take place on Day 0 as per institutional guidelines
-
Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
干预措施: Cytarabine (Drug)
ASCT + BEAM + Blinatumomab
-
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed:
-
carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7
-
etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses)
-
cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses)
-
melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2
-
Auto-SCT will take place on Day 0 as per institutional guidelines
-
Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
干预措施: Melphalan (Drug)
ASCT + BEAM + Blinatumomab
-
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed:
-
carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7
-
etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses)
-
cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses)
-
melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2
-
Auto-SCT will take place on Day 0 as per institutional guidelines
-
Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
干预措施: Peripheral blood draws (Procedure)
结局指标
主要结局
Feasibility and tolerability of blinatumomab consolidation post auto-SCT as measured by percentage of patients who can finish a full course of blinatumomab post-auto-SCT
时间窗: Up to Day 70
-The primary endpoint is calculated by the proportion of patients who complete a full course of blinatumomab to the total number of patients started blinatumomab after auto-SCT.
次要结局
- Complete remission rate in patients with residual disease after auto-SCT(Up to Day 100)
- Overall survival(3 years post-auto-SCT)
- Progression-free survival (PFS)(3 years post-auto-SCT)