A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.
详细描述
Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including:
- Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission.
- Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma.
- Myelodysplastic Syndrome (MDS)
- Blastic plasmacytoid dendritic cell neoplasm
Primary Objective:
The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis.
Secondary Objectives:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Subjects 18-70 years old.
- •Donor must be 18 years of age.
- •HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required.
- •Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
- •Acute Leukemias.
- •Acute Lymphoblastic Leukemia in high risk 1st complete response (CR1)
- •Acute Myelogenous Leukemia in high risk 1st complete response (CR1)
- •Acute Leukemias in 2nd or subsequent Complete Response (CR)
- •Biphenotypic/Undifferentiated Leukemias in 1st or subsequent Complete Response (CR).
- •Burkitt's lymphoma: second or subsequent Complete Response (CR).
- •Patients with adequate physical function
- •Performance status: Karnofsky score 70-100%.
排除标准
- 未提供
研究组 & 干预措施
cyclophosphamide post BMT
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
干预措施: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant (Drug)
结局指标
主要结局
Overall Survival
时间窗: Day 180
180 days after transplantation
次要结局
未报告次要终点
研究者
Caitlin Costello, MD
Assistant Clinical Professor
University of California, San Diego