NCT00365287已完成1 期
Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 148
- 主要终点
- Safety as assessed by a non-relapse mortality < 30% within day 100
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy and radiation therapy before a donor umbilical cord 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 when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation before donor umbilical cord blood transplant and to see how well they work in treating patients with advanced hematologic cancer, metastatic breast cancer, or kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of nonmyeloablative preparative regimen comprising cyclophosphamide, fludarabine, and total-body irradiation with or without anti-thymocyte globulin, in terms of non-relapse mortality at day 100 post-transplantation, in patients with advanced hematologic malignancies, metastatic breast cancer, or renal cell cancer who are undergoing umbilical cord blood transplantation from an unrelated donor.
Secondary
- Determine the hematopoietic recovery and degree of chimerism on days 21, 60, 100, 180, and 360 post-transplantation.
- Determine the incidence of grade II-IV and III-IV acute graft-versus-host disease (GVHD) by day 100 post-transplantation and chronic GVHD at 1 year post-transplantation.
- Evaluate the risk of relapse at 1 year post-transplantation.
- Determine overall survival at 1 year post-transplantation.
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
- — 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Acute myeloid leukemia (AML), meeting 1 of the following criteria:
- •In first complete remission (CR1) by morphology AND at high risk, as evidenced by 1 of the following:
- •AML secondary to myelodysplastic syndromes (MDS)
- •High-risk cytogenetics, such as those associated with MDS or complex karyotype
- •More than 2 courses of therap were required to obtain a CR
- •In second or greater CR by morphology
- •In morphologic relapse or persistent disease, defined as > 5% blasts in normocellular bone marrow OR any percentage of blasts if blasts have unique morphologic markers (e.g., auer rods)
- •In cytogenetic relapse (without morphologic relapse)
- •Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
- •In CR1 by morphology AND at high risk, as evidenced by 1 of the following:
- •High-risk cytogenetics, such as t(9;22), t(1;19), t(4;11), or other MLL rearrangements
- •More than 1 course of therapy was required to obtain a CR
- •In second or greater CR by morphology
- •In morphologic relapse or persistent disease as defined for AML
- •In cytogenetic relapse (without morphologic relapse)
- •Chronic myelogenous leukemia
- •All types allowed except refractory blast crisis
- •Non-Hodgkin's lymphoma (NHL)
- •No intermediate- or high-grade NHL or mantle cell NHL that is progressive on salvage therapy
- •Stable disease allowed provided it is non-bulky
- •Hodgkin's lymphoma
- •No progressive disease on salvage therapy
- •Stable disease allowed provided it is non-bulky
- •Chronic lymphocytic leukemia
- •Multiple myeloma
- •Any subtype allowed, including refractory anemia if there is severe pancytopenia or complex cytogenetics
- •Less than 5% blasts
- •If patient has blasts ≥ 5% then they must undergo induction therapy before transplantation
- •Metastatic breast cancer
- •Disease must have responded to recent chemotherapy OR in plateau after response to chemotherapy
- •Renal cell cancer
- •Acquired bone marrow failure syndromes
- •Small percentage of blasts that is equivocal between marrow regeneration vs early relapse allowed provided there are no associated cytogenetic markers consistent with relapse (for patients with AML or ALL)
- •Must have a 4/6 HLA-A, -B, and -DRB1 matched unrelated umbilical cord blood donor available
- •No 5/6 or 6/6 HLA-A , -B, and -DRB1 matched sibling donor available
- •No more than 2 antigen mismatches at the HLA-A, -B, or -DRB1 loci NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100% OR Lansky performance status 50-100% (pediatric patients)
- •Albumin > 2.5 g/dL
- •Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance > 40 mL/min (pediatric patients)
- •Adults with creatinine > 1.2 mg/dL or a history of renal dysfunction must have a creatinine clearance > 40 mL/min
- •Transaminases < 5 times upper limit of normal (ULN)
- •Bilirubin < 3 times ULN
- •LVEF ≥ 35%
- •DLCO > 30% of predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety as assessed by a non-relapse mortality < 30% within day 100
次要结局
- Hematopoietic recovery and the degree of chimerism at days 21, 60, 100, 180, and 360 after study completion
研究者
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