A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 5
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（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
Allo-HSCT + TLI + ATG
Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
- Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
- Anti-thymocyte globulin (ATG) Days -11 to -7
- Methylprednisolone Days -11 to -7
- Cyclosporine (CSP) Days -4 to +2
- 5+ of 6 HLA-matched CD34+ cells on Day 0
- Mycophenolate mofetil (MMF), Day 0 to Day +28
干预措施: Allogeneic HSCT (Procedure)
Allo-HSCT + TLI + ATG
Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
- Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
- Anti-thymocyte globulin (ATG) Days -11 to -7
- Methylprednisolone Days -11 to -7
- Cyclosporine (CSP) Days -4 to +2
- 5+ of 6 HLA-matched CD34+ cells on Day 0
- Mycophenolate mofetil (MMF), Day 0 to Day +28
干预措施: Anti-thymocyte globulin (ATG) (Drug)
Allo-HSCT + TLI + ATG
Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
- Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
- Anti-thymocyte globulin (ATG) Days -11 to -7
- Methylprednisolone Days -11 to -7
- Cyclosporine (CSP) Days -4 to +2
- 5+ of 6 HLA-matched CD34+ cells on Day 0
- Mycophenolate mofetil (MMF), Day 0 to Day +28
干预措施: Cyclosporine (CSP) (Drug)
Allo-HSCT + TLI + ATG
Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
- Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
- Anti-thymocyte globulin (ATG) Days -11 to -7
- Methylprednisolone Days -11 to -7
- Cyclosporine (CSP) Days -4 to +2
- 5+ of 6 HLA-matched CD34+ cells on Day 0
- Mycophenolate mofetil (MMF), Day 0 to Day +28
干预措施: Mycophenolate mofetil (MMF) (Drug)
Allo-HSCT + TLI + ATG
Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
- Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
- Anti-thymocyte globulin (ATG) Days -11 to -7
- Methylprednisolone Days -11 to -7
- Cyclosporine (CSP) Days -4 to +2
- 5+ of 6 HLA-matched CD34+ cells on Day 0
- Mycophenolate mofetil (MMF), Day 0 to Day +28
干预措施: Total lymphoid irradiation (TLI) (Radiation)
Allo-HSCT + TLI + ATG
Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
- Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
- Anti-thymocyte globulin (ATG) Days -11 to -7
- Methylprednisolone Days -11 to -7
- Cyclosporine (CSP) Days -4 to +2
- 5+ of 6 HLA-matched CD34+ cells on Day 0
- Mycophenolate mofetil (MMF), Day 0 to Day +28
干预措施: Methylprednisolone sodium succinate (Drug)
Best Standard Care
Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:
- Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
- Autologous transplantation
- Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
- Umbilical cord blood transplantation
- Haploidentical transplantation
干预措施: Best standard care (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 2 years
Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion).
次要结局
- Early Graft Loss(2 years)
- Disease-free Survival (DFS)(2 years)
- Non-relapse Mortality(2 years)
- Complete Donor Hematopoietic Cell Chimerism(2 years)
- Patients Completing the Intended Therapy in Both Arms(2 years)
- Relapse Rate(2 years)
- Transplant-related Mortality(100 days and 6 months)
研究者
Robert Lowsky
Professor of Medicine
Stanford University