NCT00453206已完成不适用
Reduced Intensity Allogeneic Hematopoietic Cell Transplantation for Patients With Hematological Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Treatment-related Mortality Within the First 6 Months After Transplantation
研究概览
简要总结
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility (i.e., risk of treatment-related mortality during the first 6 months after transplantation) of administering reduced-intensity allogeneic hematopoietic stem cell transplantation to patients with hematologic cancer or other diseases.
Secondary
- Determine the response rate (partial and complete response), 6- and 12-month probabilities of response, and time to progression in patients treated with this regimen.
- Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine other toxicities of this regimen in these patients.
- Determine the overall survival and disease-free survival of patients treated with this regimen.
- Determine the impact of iron status on overall and disease-free survival.
- Determine the influence of quality of life (at time of transplantation) on overall survival.
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed hematological disease, including any of the following:
- •Chronic lymphocytic leukemia
- •Absolute lymphocytosis > 5,000/µL
- •Morphologically mature lymphocytes with < 55% prolymphocytes
- •Lymphocyte phenotype with expression of CD19 and CD5
- •Absence of CD23 expression allowed provided disease is morphologically distinguished from mantle cell lymphoma
- •Prolymphocytic leukemia
- •Absolute lymphocytosis > 5,000/µL
- •Morphologically mature lymphocytes with > 55% prolymphocytes
- •Non-Hodgkin's or Hodgkin's lymphoma
- •Any WHO classification histologic subtype
- •Diagnosis by core biopsy allowed provided there is adequate tissue for diagnosis and immunophenotyping
- •Diagnosis by bone marrow biopsy not acceptable for follicular lymphomas
- •Multiple myeloma
- •Has received ≥ 1 prior treatment regimen
- •Has a partial response or greater by the Blade Criteria
- •Patients who achieved complete remission are eligible
- •Acute myeloid leukemia
- •Documented control (i.e., < 10% bone marrow blasts and no circulating blasts)
- •Myelodysplastic syndromes
- •Documented disease as defined by WHO or French-American-British Cooperative group criteria
- •Chronic myelogenous leukemia
- •Patients with atypical chronic myelogenous leukemia (i.e., absent Philadelphia chromosome) are eligible
- •Polycythemia vera
- •Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B):
- •A1: Total red blood cell mass > 25% above mean normal predicted value OR hemoglobin > 18.5 g/dL in males, 16.5 g/dL in females (hematocrit ≥ 60% in males or ≥ 56% in females)
- •A2: No cause of secondary erythrocytosis (absence of familial erythrocytosis, no elevation of epoetin alfa [EPO] due to hypoxia, high oxygen affinity hemoglobin, truncated EPO receptor, or inappropriate ectopic EPO production)
- •A3: Splenomegaly
- •A4: Clonal genetic abnormality other than the Philadelphia chromosome
- •A5: Endogenous erythroid colony formation in vitro
- •B: Platelet count > 400,000/mm³, WBC > 12,000/mm³, bone marrow biopsy with prominent erythroid and megakaryocytic proliferation, and low serum EPO
- •Chronic idiopathic myelofibrosis
- •Documented disease as defined by WHO criteria
- •Must have a HLA-identical donor, a matched unrelated donor, or a HLA 9/10 related donor meeting the following criteria:
- •HLA-identical sibling (6/6)
- •Serologic typing for class I (A, B)
- •Molecular typing for class II (DRB1)
- •9/10 matched related donor
- •High-resolution molecular typing at HLA-A, B, C, DRB1, and DQB1
- •Only a single mismatch at one class I or II allele allowed
- •10/10 matched unrelated donor
- •Molecular identity at HLA-A, B, C, DRB1, and DQB1 by high-resolution typing
- •Syngeneic donors are not eligible
- •Creatinine clearance ≥ 40 mL/min
- •Bilirubin ≤ 3 times upper limit of normal (ULN)
- •AST ≤ 3 times ULN
- •DLCO ≥ 40% with no symptomatic pulmonary disease
- •LVEF ≥ 30% by cardiac MRI or echocardiogram with no symptomatic cardiac disease
- •Fertile patients willing to use effective contraception
排除标准
- •Uncontrolled diabetes mellitus
- •Active serious infection
- •Known hypersensitivity to E. coli-derived products
- •Known HIV positivity
- •History of another malignancy*, meeting the following criteria:
- •Non-skin malignancy or melanoma within the past 5 years
- •Concomitant malignancy that has not been curatively treated
- •NOTE: *However, cancer survivors who have undergone potentially curative therapy for a prior malignancy at least 5 years before enrollment and are deemed at low risk of < 30% for recurrence by their treating physicians is considered
- •Pregnant or nursing
结局指标
主要结局
Treatment-related Mortality Within the First 6 Months After Transplantation
时间窗: 6 months
次要结局
- Overall Survival(monthly)
- Disease-free Survival(monthly)
- Graft-versus-host Disease(monthly)
- Iron Status at the Time of Transplantation(baseline)
- Quality of Life at the Time of Transplantation(baseline)
- Treatment-related Mortality at 100 Days After Transplantation(100 days)
- Complete Response(monthly)
研究者
研究点 (2)
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