NCT00301912撤回2 期
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Treatment-related mortality in the first 100 days post-transplant
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Tacrolimus and methotrexate may stop this from happening.
PURPOSE: This phase II trial is studying how well giving busulfan together with fludarabine before donor stem cell transplant works in treating patients with hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety, in terms of treatment-related mortality at 100 days post-transplantation, of a myeloablative preparative regimen comprising busulfan and fludarabine and graft-vs-host disease (GVHD) prophylaxis comprising tacrolimus and methotrexate in patients with hematopoietic disorders undergoing matched unrelated donor stem cell transplantation.
- Determine the efficacy, in terms of overall survival at 1-year post-transplantation, in patients treated with this regimen.
Secondary
- Determine organ toxicity in patients treated with this regimen.
- Determine neutrophil and platelet recovery in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic GVHD in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following hematopoietic disorders:
- •Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
- •Chronic phase disease failing imatinib mesylate therapy
- •Progressive disease OR failed to achieve a major cytogenetic response at 1 year after initiation of therapy
- •Accelerated phase disease, meeting 1 of the following criteria:
- •Failed to achieve complete cytogenetic remission at 1 year after initiation of therapy
- •Failed to achieve any cytogenetic response at 3 or 6 months during therapy
- •Progressive disease, demonstrated by worsening cytogenetic response in 2 consecutive analyses separated by 4 weeks
- •Blast crisis with < 10% blasts in bone marrow within 6 weeks of transplantation
- •Acute myeloid leukemia (AML), meeting 1 of the following criteria:
- •In second or greater remission
- •In first remission with poor prognosis cytogenetics [-5, -5q, -7, -7q and ≥ 2 cytogenetic abnormalities, t(6,9), t(9,11), or Philadelphia chromosome]
- •In hematologic remission but with persistent cytogenetic abnormalities
- •Primary refractory AML with < 10% blasts in bone marrow within 6 weeks of transplantation
- •Myelodysplasia with < 20% blasts in bone marrow within 6 weeks of transplantation and meeting 1 of the following criteria:
- •Advanced disease (International Prognostic Scoring System [IPSS] score intermediate-1, intermediate-2, or high risk)
- •Myelodysplastic syndromes (MDS) with progression to AML
- •Treatment-related AML
- •Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:
- •In second or greater remission
- •In first remission with high-risk cytogenetics [Philadelphia chromosome; t(4,11); and -7]
- •Primary refractory ALL with < 10% blasts in the bone marrow
- •Severe aplastic anemia that has failed immunosuppressive therapy
- •Non-Hodgkin's lymphoma, meeting 1 of the following criteria:
- •In second or greater remission
- •Relapsed disease in a patient not eligible for autologous stem cell transplantation
- •Lymphoproliferative disease (e.g., chronic lymphocytic leukemia or Waldenstrom's macroglobulinemia), meeting 1 of the following criteria:
- •In second or greater remission
- •Relapsed disease in a patient not eligible for autologous stem cell transplantation
- •Multiple myeloma, meeting 1 of the following criteria:
- •Stage II or III disease in first or greater relapse
- •Refractory disease
- •Newly diagnosed disease with chromosome 13 abnormalities
- •Advanced myeloproliferative disease, meeting 1 of the following criteria:
- •Myelofibrosis requiring > 2 units of packed red blood cells each month
- •Essential thrombocythemia or polycythemia rubra vera that has progressed to AML
- •Failed prior AML therapy
- •No active, uncontrolled CNS leukemia
- •Not eligible for autologous or mini-allogeneic transplantation
- •No fully matched or single-antigen mismatched sibling donor available
- •HLA-matched unrelated donor available
- •HLA typed at HLA-A, -B, -C, -DRB1 and/or -DQB1 by high-resolution techniques
- •For patients without HLA identical donors, mismatches at DQ (i.e., 8/8 match) and 1 additional mismatch at the allele level at HLA-A, -B, -C, or -DRB1 (i.e., 7/8 molecular match) allowed
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Creatinine < 2.0 mg/dL
- •Pulmonary diffusing capacity > 40% of predicted
- •Cardiac ejection fraction > 40% by MUGA or echocardiography
- •No active liver disease
- 另有 13 项未显示
排除标准
- 未提供
结局指标
主要结局
Treatment-related mortality in the first 100 days post-transplant
Overall survival at 1 year post-transplant
次要结局
- Incidence and severity of organ-specific toxicity
- Engraftment including neutrophil and platelet recovery and donor chimerism at 3 and 12 months post-transplant
- Rate of acute graft-vs-host disease (GVHD)
- Rate of chronic GVHD
研究者
研究点 (2)
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