A Phase I Trial to Determine Safety and Tolerability of Ex Vivo Expanded Human Myeloid Progenitor Cells (CLT-008) Infused 24 Hours Post-Transplant to Support Allogeneic Umbilical Cord Blood Transplantation for Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- Safety and tolerability
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 in patients receiving myeloablative conditioning as part of an umbilical cord blood transplant for hematologic cancer. In this study, the safety and tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will be determined by monitoring for adverse reactions, neutrophil and platelet recovery, hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x 10e7 cells/kg for hematological malignancy:
- •High risk acute myeloid leukemia (AML) in complete remission
- •Very high risk pediatric AML; patients <21 years eligible with <25% blasts in marrow after failed chemotherapy
- •High risk acute lymphocytic leukemia (ALL) in complete remission
- •Chronic myelogenous leukemia (CML), excluding refractory blast crisis
- •Myelodysplasia (MDS) IPPS Int-2 or high risk, or refractory anemia with severe pancytopenia or high risk cytogenetics
- •Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after two prior therapies
- •Lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after initial therapy and complete or partial remission
- •Large cell non-Hodgkin lymphoma (NHL) in second complete or partial remission (chemotherapy refractory large cell NHL not eligible)
- •Lymphoblastic lymphoma, peripheral T cell lymphoma including angioimmunoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in complete or partial remission, or after progression if stage I/II <1 year (chemotherapy refractory high-grade NHL not eligible)
- •Multiple myeloma beyond 2nd partial remission
- •Preparative regimen consisting of cyclophosphamide, fludarabine, and total body irradiation
- •Adequate organ function
排除标准
- •Symptomatic underlying pulmonary disease or requiring oxygen
- •Active infection
- •HIV positive
- •Pregnant or nursing
研究组 & 干预措施
Group B
Low dose, multiple donor CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Group A
Low dose, single donor CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Group C
Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
Group D
High dose, multiple donor CLT-008 (human myeloid progenitor cells)
干预措施: human myeloid progenitor cells (Biological)
结局指标
主要结局
Safety and tolerability
时间窗: 100 days post transplant
次要结局
- Neutrophil and platelet recovery(100 days post transplant)
- Persistence of CLT-008 derived cells(100 days post transplant)
- Infections(42 days post transplant)
- Graft-versus-host disease (GVHD)(100 days post transplant)
- Non-relapse mortality(100 days post transplant)