Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells

Masonic Cancer Center, University of Minnesota1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2006年2月最近更新: 2017年12月28日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Masonic Cancer Center, University of Minnesota
入组人数: 16
试验地点: 1
主要终点: Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Giving chemotherapy, natural killer cells, aldesleukin, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells and cancer 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 cyclosporine, mycophenolate mofetil, and methylprednisolone before and after transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by donor umbilical cord blood natural killer cells, aldesleukin, and umbilical cord blood transplant works in treating patients with refractory hematologic cancer or other diseases.

详细描述

OBJECTIVES:

Primary

Determine the incidence of 6-month disease free survival. The primary laboratory objective is the measure of in vivo expansion of umbilical cord blood (UCB) derived natural killer cells (NK) after a fully ablative preparative regimen.

Secondary

Determine the incidence of transplant-related mortality at 6 months after NK UCB + double UCBT
Evaluate the pattern of chimerism after NK UCB + double UCBT
Determine the incidence of neutrophil engraftment at day 42 after NK UCB + double umbilical cord blood transplantation (UCBT)
Determine the incidence of platelet engraftment at 6 months after NK UCB + double UCBT
Determine the incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade III-IV at day 100 after NK UCB + double UCBT
Determine the incidence of chronic GVHD at 1 year after NK UCB + double UCBT
Determine the disease-free survival at 1 after NK UCB + double UCBT
Determine the incidence of relapse at 1 after NK UCB + double UCBT

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 45 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of 1 of the following:
•Acute myeloid leukemia with active leukemia (i.e., not in complete remission [CR]), defined by light microscopy (bone marrow) and having failed ≥ 1 round of standard chemotherapy
•Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after ≥ 1 course of standard chemotherapy and imatinib mesylate
•Myelodysplastic syndromes (MDS) or other myeloproliferative disorders more than 10% blasts after ≥ 1 course of standard chemotherapy
•Unrelated umbilical cord blood (UCB) donor(s) available - Each unit must be 4-6/6 HLA-A, -B, and -DRB1 matched with the recipient (and to each other if 2 units are utilized) (for UCB graft) AND 3/6 HLA-A, -B, and -DRB1 matched with the recipient (for UCB natural killer [NK] cells)
•Karnofsky performance status (PS) 80-100% (adult patients) or Lansky PS 50-100% (pediatric patients)
•Creatinine ≤ 2.0 mg/dL (adult patients) OR creatinine clearance > 40 mL/min (pediatric patients)
•Bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
•Corrected Carbon Monoxide Diffusing Capacity (DLCO) > 50% normal OR oxygen saturation > 92% (in pediatric patients who cannot undergo pulmonary function tests)
•Left ventricular ejection fraction ≥ 45%

排除标准

•Pregnant or nursing
•Positive pregnancy test (Fertile patients must use effective contraception)
•History of HIV infection
•Active infection at time of transplantation
•Active infection with Aspergillus or other mold within the past 120 days
•Less than 6 months since prior myeloablative transplant (≤ 18 years old)
•Prior myeloablative allotransplant or autologous transplant (> 18 years old)
•No prior extensive therapy including > 12 months of any alkylator chemotherapy or > 6 months of alkylator therapy with extensive radiation (e.g., mantle irradiation for Hodgkin's lymphoma)
•Prior radiation therapy that would make the patient ineligible for total-body irradiation