A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 146
- 试验地点
- 36
- 主要终点
- Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection
研究概览
简要总结
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.
详细描述
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced neutropenia (CIN) in adult subjects with AML.
Eligible subjects with untreated de novo or secondary AML and per local institutional standards planned to receive at least two cycles of chemotherapy with curative intent will be enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of Care [SOC] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC chemotherapy).
Subjects randomized to an Investigational Arm will be eligible to receive a single fixed assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle). Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy.
All subjects will be followed for 84 days following randomization, or 30 days post final infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control Arm, whichever is longer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an open-label study.
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
- •Age ≥ 18 (or legal age of majority for sites outside US).
- •Untreated de novo or secondary acute myeloid leukemia (AML), including AML that has progressed from myelodysplastic syndrome (MDS), and histologically documented diagnosis
- •Eligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intent
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 or Karnofsky Status of 50 to
- •Adequate cardiac, renal, and hepatic functions.
排除标准
- •Extramedullary disease in the absence of bone marrow or blood involvement
- •Acute promyelocytic leukemia (APL) with PML-RARA
- •Prior AML therapy, with the exception of intrathecal chemotherapy or emergent radiation for myeloid sarcoma.
- •Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation
- •Prior allotransplant, including allogeneic hematopoietic cell transplant or solid organ allogeneic transplant
- •Known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (DMSO)
- •Active/chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection
研究组 & 干预措施
Control Arm
The Control Arm will receive standard of care (SOC) chemotherapy without the infusion of NLA101. SOC chemotherapy will be determined by local PI and must be a standard regimen for untreated de novo or secondary AML that will result in moderate to severe myelosuppression and will be given with curative intent.
干预措施: Standard of Care (SOC) chemotherapy (Drug)
Low Dose Arm
The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
干预措施: NLA101 (Biological)
Low Dose Arm
The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
干预措施: Standard of Care (SOC) chemotherapy (Drug)
Medium Dose Arm
The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
干预措施: NLA101 (Biological)
Medium Dose Arm
The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
干预措施: Standard of Care (SOC) chemotherapy (Drug)
High Dose Arm
The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
干预措施: NLA101 (Biological)
High Dose Arm
The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
干预措施: Standard of Care (SOC) chemotherapy (Drug)
结局指标
主要结局
Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection
时间窗: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
次要结局
- Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy(From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later)
- Incidence and duration of complications due to infections(From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later)
- Incidence and duration of febrile neutropenia(From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later)
- Incidence and duration of filgrastim (or biosimilar) administration(From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later)
- Overall Response Rate(From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later)