NCT00897260已完成不适用
Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
研究概览
简要总结
To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a histologically confirmed diagnosis at The Vancouver General Hospital or the BCCA-Vancouver.
- •Eligible patients will have one of the following underlying diseases:
- •High risk acute lymphoblastic leukemia (ALL) in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22) or t(1;19) or patients presenting with extreme hyperleukocytosis (WBC >100x109/L) or failure to achieve a complete remission after standard induction therapy.
- •Acute myeloid leukemia (AML) in first complete remission with high risk cytogenetics or failure to achieve complete remission after standard induction therapy. ALL or AML in second or subsequent remission
- •Myelofibrosis with myeloid metaplasia.
- •Chronic myeloid leukemia in chronic (failed interferon and/or Gleevec) or accelerated phase.
- •Myelodysplastic syndrome with IPSS risk category >Int-1
- •Aplastic anemia
- •Non-Hodgkin's lymphoma, chronic lymphocytic leukemia or Hodgkin's disease in relapse or second or subsequent remission.
- •Multiple Myeloma
- •No active central nervous system (CNS) disease.
- •No 9/10 or better HLA antigen matched related donor or VUD available.
- •The patient's condition precludes waiting to search and find a VUD in the Unrelated Donor Registries
- •Acceptance of standard blood product support
- •Adequate organ function as defined by current Leukemia/BMT Program of BC standards (Appendix 10.1)
- •Karnofsky performance status ≥ 80 (Appendix 10.2)
排除标准
- •Active infection
- •Pregnancy
- •Significant psychiatric disorder
- •Progressive disease
研究组 & 干预措施
1
Experimental
干预措施: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders (Procedure)
结局指标
主要结局
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
时间窗: 1 year
次要结局
- To determine the 100-day treatment related mortality (TRM), complete remission rate and the 2-year progression free and overall survival rate for patients under going this treatment.(100 days)
- To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.(1 year)
- To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis(1 year)
- To determine rate of hematologic engraftment following umbilical cord blood transplantation with 1-2 cord blood units using total body irradiation & fludarabine as transplant conditioning regimen & cyclosporine/MMF as graft-vs-host disease prophylaxis(1 year)
研究者
Donna E. Hogge
Principal Investigator
University of British Columbia
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DMImmunologic Deficiency SyndromesDiabetes Mellitus, Type 1NCT03835312Children's Hospital of Fudan University50
终止
2 期
A Phase II Study of Umbilical Cord Blood TransplantationLymphomaLeukemiaAplastic AnemiaMultiple MyelomaNCT00676806Tufts Medical Center7
终止
不适用
Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological DiseasesAcute Myeloid Leukemia (AML)Acute Lymphocytic Leukemia (ALL)Burkitt's LymphomaPlasma Cell LeukemiaMyelodysplasiaSmall Lymphocytic LymphomaMarginal Zone B-Cell LymphomaLymphoplasmacytic LymphomaMantle-Cell LymphomaDiffuse Large B Cell LymphomaLymphoblastic LymphomaNon-Hodgkin LymphomaMultiple MyelomaChronic Lymphocytic LeukemiaProlymphocytic LeukemiaChronic Myelogenous LeukemiaFollicular LymphomaMyelofibrosisNCT01962636Masonic Cancer Center, University of Minnesota200
已完成
2 期
Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic DiseaseAcute Biphenotypic LeukemiaBurkitt LymphomaAcute Myeloid LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveLymphoblastic LymphomaLymphoplasmacytic LymphomaMarginal Zone LymphomaChronic Lymphocytic LeukemiaNon-Hodgkin LymphomaPlasma Cell MyelomaSmall Lymphocytic LymphomaProlymphocytic LeukemiaRefractory AnemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeMantle Cell LymphomaFollicular LymphomaMyelofibrosisNCT00719888Fred Hutchinson Cancer Center135
已完成
2 期
Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic DisordersMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLymphomaLeukemiaNCT00055653Roswell Park Cancer Institute