A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin, as Graft-versus-Host Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
研究概览
简要总结
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, antithymocyte globulin, and methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte globulin work in preventing graft-versus-host disease in patients undergoing a donor stem cell transplant for hematological cancer .
详细描述
OBJECTIVES:
Primary
- To determine the incidence and severity of acute- and chronic-graft-versus-host disease (GVHD) after HLA-matched or -mismatched unrelated donor hematopoietic peripheral blood transplantation in patients with hematologic malignancies scheduled to receive immunosuppressive combination of sirolimus, tacrolimus, and anti-thymocyte globulin as GVHD prophylaxis.
- To determine the safety of this combination in the first six months post-transplant.
Secondary
- To determine the time-to-engraftment, non-relapse mortality rate, overall and disease-free survival, incidence of disease relapse, and incidence of opportunistic infections with this GVHD prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, 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
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: anti-thymocyte globulin (Biological)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: fludarabine phosphate (Drug)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: melphalan (Drug)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: methotrexate (Drug)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: sirolimus (Drug)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: tacrolimus (Drug)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: hematopoietic stem cell transplantation (Procedure)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: peripheral blood stem cell transplantation (Procedure)
Fludarabine/Melphalan Conditioning
Fludarabine/Melphalan Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: total-body irradiation (Radiation)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: anti-thymocyte globulin (Biological)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: cyclophosphamide (Drug)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: methotrexate (Drug)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: sirolimus (Drug)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: tacrolimus (Drug)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: hematopoietic stem cell transplantation (Procedure)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: peripheral blood stem cell transplantation (Procedure)
FTBI/Cytoxan Conditioning
FTBI/Cytoxan Conditioning with Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: total-body irradiation (Radiation)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: anti-thymocyte globulin (Biological)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: etoposide (Drug)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: methotrexate (Drug)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: sirolimus (Drug)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: tacrolimus (Drug)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: hematopoietic stem cell transplantation (Procedure)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: peripheral blood stem cell transplantation (Procedure)
FTBI/Etoposide Conditioning
FTBI/Etoposide Conditioning with
Sirolimus, Tacrolimus and rabbit anti-thymocyte globulin (+/- methotrexate) for GvHD Prophylaxis
干预措施: total-body irradiation (Radiation)
结局指标
主要结局
Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
时间窗: 100 Days Post Hematopoietic Stem Cell Transplant (HSCT)
Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
Severity of Acute GVHD
时间窗: 100 Days Post HSCT
All patients were considered for the evaluation of the severity of acute GVHD.
Cumulative Incidence of Chronic GVHD
时间窗: 2 year point estimate was provided.
Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.
Severity of Chronic GVHD
时间窗: Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT
All Patients were considered for the evaluation of chronic GVHD severity.
次要结局
- Time to Absolute Neutrophil Count Recovery (Engraftment)(Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT)
- Time to Platelet Count Recovery (Engraftment)(Patients were evaluated until platelet recovery, a median of 14 days)
- Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation(Median Follow Up: 28 months (Range: 1-49 months))
- Occurrence of Thrombotic Microangiopathy(Median Follow Up: 28 Months (Range: 1-49 months))
- Occurence of Sinusoidal Obstructive Syndrome (SOS)(Median Follow Up: 28 Months (Range: 1-49 Months))
- Non-relapse Mortality at 100 Days Post HSCT(100 day point estimate was provided)
- Non-relapse Mortality at Two Years Post HSCT(2 year point estimate was provided.)
- Overall Survival at Two Years Post HSCT(2 year point estimate was provided.)
- Event Free Survival at Two Years Post HSCT(2 year point estimate was provided.)
- Incidence of Disease Relapse/Progression at 2 Years Post HSCT(2 year point estimate was provided.)