Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
研究概览
简要总结
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
详细描述
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)
However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages between 0 to and 65 years of age.
- •Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
- •Acute lymphocytic leukemia (ALL) in CR1 with high risk features
- •Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
- •i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]
- •Acute Leukemias in 2nd or greater remission
- •Refractory or Relapsed AML
- •AML transformed from MDS
- •Myelodysplastic syndrome (MDS) beyond refractory anemia
- •Chronic myeloid leukemia (CML)
- •Chronic myelomonocytic leukemia
- •Philadelphia-negative myeloproliferative disorder
- •Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
- •Multiple Myeloma-Stage III
排除标准
- •Prior autologous or allogeneic stem cell transplant.
- •Performance status greater than 2
- •Active infection.
- •Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
- •Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
- •Inadequate Serum creatinine clearance <60
- •InadequatebHepatic function
- •Positive serology for HIV-1, 2 or HTLV-1,
- •Pregnancy. Female patient must have negative pregnancy test
结局指标
主要结局
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
时间窗: 1 year
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
次要结局
未报告次要终点