A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 10
- 主要终点
- Incidence of serious adverse reactions
研究概览
简要总结
Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after "standard of care" cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Hematological malignancy, including:
- •AML, ALL or MDS
- •Planned treatment with cytarabine-based chemotherapy regimen
- •Adequate hepatic, renal, hematologic, cardiac and respiratory function
排除标准
- •Prior allograft or history of active GVHD within 3 years
- •Pregnant or nursing
研究组 & 干预措施
Consolidation Group A
Low dose CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Consolidation Group A
Low dose CLT-008 (human myeloid progenitor cells)
干预措施: G-CSF (Drug)
Consolidation Group B
Intermediate dose CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Consolidation Group B
Intermediate dose CLT-008 (human myeloid progenitor cells)
干预措施: G-CSF (Drug)
Consolidation Group C
Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF
干预措施: human myeloid progenitor cells (Biological)
Consolidation Group D
High dose CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Consolidation Group D
High dose CLT-008 (human myeloid progenitor cells)
干预措施: G-CSF (Drug)
Induction Group A1 (cytarabine 7+3)
G-CSF
干预措施: G-CSF (Drug)
Induction Group A2 (cytarabine 7+3)
Intermediate dose CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Induction Group A2 (cytarabine 7+3)
Intermediate dose CLT-008 (human myeloid progenitor cells)
干预措施: G-CSF (Drug)
Induction Group A3 (cytarabine 7+3)
High dose CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Induction Group A3 (cytarabine 7+3)
High dose CLT-008 (human myeloid progenitor cells)
干预措施: G-CSF (Drug)
Induction Group B1 (cytarabine HIDAC)
G-CSF
干预措施: G-CSF (Drug)
Induction Group B2 (cytarabine HIDAC)
Intermediate dose CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Induction Group B2 (cytarabine HIDAC)
Intermediate dose CLT-008 (human myeloid progenitor cells)
干预措施: G-CSF (Drug)
Induction Group B3 (cytarabine HIDAC)
High dose CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Induction Group B3 (cytarabine HIDAC)
High dose CLT-008 (human myeloid progenitor cells)
干预措施: G-CSF (Drug)
结局指标
主要结局
Incidence of serious adverse reactions
时间窗: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
次要结局
- Incidence of mucositis(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Duration of thrombocytopenia(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Incidence of infections(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Duration of hospitalization(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Duration of antibiotic use(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Duration of presence of CLT-008 derived cells in blood(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Duration of presence of CLT-008 derived cells in bone marrow(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Duration of fever(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Duration of neutropenia(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)
- Incidence of hospitalization(Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose)