NCT00295880终止1 期
A Phase I/II Study of Double Unit Umbilical Cord Blood (UCB) Transplantation Utilizing Graft Administration Via Intra-Bone Marrow Injection (Companion Protocol to MT2000-25)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Median Number of Days to Neutrophil Engraftment
研究概览
简要总结
Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor's umbilical cord blood are injected into the patient's bone marrow they may help make stem cells, red blood cells, white blood cells, and platelets.
Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood transplant when given directly into the bone marrow and to see how well it works in treating patients with hematologic cancer.
详细描述
Objectives:
Primary
- Determine the safety, in terms of infusional toxicity, of myeloablative unrelated donor double-unit umbilical cord blood (UCB) transplantation via intra-bone marrow injection (IBMI) in patients with advanced or high-risk hematologic malignancy.
- Determine whether treatment with this regimen improves the time to neutrophil engraftment (compared to historical controls) in these patients.
Secondary
- Determine the incidence of sustained donor engraftment in patients treated with this regimen.
- Determine the relative contribution of each UCB unit to initial and sustained donor engraftment in these patients.
- Determine the incidence of grade II-IV and grade III-IV acute graft-vs-host disease (GVHD) and chronic GVHD in patients treated with this regimen.
- Determine the incidence of day 100 and 180 transplant-related mortality in patients treated with this regimen.
- Determine the probability of survival at 100 days and 1 year post-transplantation in these patients.
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
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myeloid leukemia (AML): high risk CR1
- •Acute lymphocytic leukemia (ALL): high risk CR1 [t(9;22), t (1:19), t(4;11) or other MLL rearrangements] or > 1 cycle to obtain CR; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
- •Chronic myelogenous leukemia (CML) excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.
- •Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics.
- •Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm).
- •Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+.
- •Large cell NHL > CR2/> PR
- •Patients in CR2/PR2 with initial short remission (<6 months) are eligible.
- •Lymphoblastic lymphoma.
- •Multiple myeloma beyond PR
- •Karnofsky performance status (PS) 90-100% (adults)
- •Lansky PS 50-100% (children)
- •Acceptable organ function
排除标准
- •Active infection at time of transplantation
- •History of HIV infection
- •Pregnant or breast feeding.
- •Chemotherapy refractory large cell and high grade NHL (ie progressive disease after > 2 salvage regimens)
- •Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation.
- •Diffuse myelofibrosis of BM (bone marrow) (any severity) regardless of primary diagnosis (focal fibrosis acceptable provided it involves < 20% of BM volume).
- •History of pelvic irradiation.
结局指标
主要结局
Median Number of Days to Neutrophil Engraftment
时间窗: Daily through Day 60 post transplant
Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.
次要结局
- Number of Patients Surviving at Day 100 and 1 Year.(Day 100 and 1 year)
- Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)(100 days post transplant)
- Number of Patients Achieving Neutrophil Recovery(6 months)
- Number of Patients With Evidence of Engraftment.(1 year)
- Number of Patients With Chronic Graft-versus-host Disease (GVHD).(1 year post transplant)
- Number of Patients With Acute Graft-versus-host Disease (GVHD)(100 days post transplant)
- Number of Patients With Transplant-related Mortality (TRM)(Day 100 and Day 180)
研究者
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