NCT00107354已完成1 期
Phase I Study of Adoptive Immunotherapy With CD8 Minor Histocompatibility (H) Antigen-Specific CTL Clones for Patients With Relapsed of AML or ALL After Allogeneic Hematopoietic Stem Cell Transplant
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes that relapsed after donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Determine the toxic effects of adoptive immunotherapy comprising CD8-positive minor histocompatability antigen-specific cytotoxic T-lymphocytes in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes that relapsed after allogeneic hematopoietic stem cell transplantation.
Secondary
- Determine the persistence of adoptively transfused T cells in vivo and assess their migration to the bone marrow in these patients.
- Determine the anti-leukemic activity of this therapy in these patients.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Undergoing allogeneic hematopoietic stem cell transplantation* from a major histocompatability complex (MHC)-identical related donor for 1 of the following:
- •Primary refractory acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
- •AML or ALL beyond first remission
- •Therapy-related AML at any stage
- •Philadelphia chromosome (bcr-abl)-positive p190-positive ALL at any stage
- •Acute leukemia at any stage arising from myelodysplastic syndromes or myeloproliferative disorders, including any of the following:
- •Chronic myelomonocytic leukemia
- •Chronic myelogenous leukemia
- •Polycythemia vera
- •Essential thrombocytosis
- •Agnogenic myeloid metaplasia with myelofibrosis
- •Refractory anemia with excess blasts
- •Refractory anemia with excess blasts in transformation NOTE: *Patients must be enrolled on study prior to undergoing transplantation
- •Relapsed disease post-transplantation, as evidenced by 1 of the following criteria:
- •Morphologic relapse, as defined by 1 or more of the following:
- •Peripheral blasts in the absence of growth factor therapy
- •Bone marrow blasts > 5% of nucleated cells
- •Extramedullary chloroma or granulocytic sarcoma
- •Flow cytometric relapse, as defined by the appearance of cells with abnormal immunophenotype consistent with leukemia relapse in the peripheral blood or bone marrow (detected before transplantation)
- •Cytogenetic relapse, as defined by the appearance in 1 or more metaphases from bone marrow or peripheral blood cells of either a non-constitutional cytogenetic abnormality detected in at least 1 cytogenetic study performed before transplantation OR a new abnormality known to be associated with leukemia
- •Molecular relapse, as defined by 1 of the following:
- •1 or more positive polymerase chain reaction (PCR) assays for clonotypic immunoglobulin heavy chain or T-cell receptor gene rearrangement in patients transplanted for B- or T-cell ALL respectively
- •1 or more positive post-transplantation reverse transcription PCR assays for p190 BCR-ABL mRNA fusion transcripts in patients transplanted for Philadelphia chromosome-positive p190-positive ALL
- •No grade III or IV acute graft-versus-host disease (GVHD)**
- •No extensive chronic GVHD** NOTE: **At time of post-transplant relapse
- •PATIENT CHARACTERISTICS:
- •14 and over (patients < 14 years of age may be eligible if they are deemed to be of sufficient height and weight by the pediatric attending physician)
- •Performance status
- •Karnofsky 60-100% (at time of post-transplant relapse)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No preexisting major nonhematopoietic organ toxicity ≥ grade 3 (at time of post-transplant relapse)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Concurrent immunosuppressive steroid therapy for GVHD allowed provided both of the following are true:
- •Able to taper steroid dose to < 0.5 mg/kg/day
- •No increase of > 1 grade in acute GVHD OR progression of chronic GVHD within 14 days after dose change
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Toxicity
次要结局
- In vivo persistence of adoptively transferred T cells
- Migration of adoptively transferred T cells to the bone marrow
- Antileukemic activity
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent SarcomaHLA-A*0201 Positive Cells PresentNY-ESO-1 Positive Tumor Cells PresentRecurrent Synovial SarcomaRecurrent Myxoid LiposarcomaNCT03450122M.D. Anderson Cancer Center15
已完成
1 期
Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2Brain Stem GliomaAnaplastic AstrocytomaAnaplastic MeningiomaGiant Cell GlioblastomaAnaplastic EpendymomaAnaplastic OligodendrogliomaEpendymoblastomaGliosarcomaGrade III MeningiomaMixed GliomaMeningeal HemangiopericytomaPineal Gland AstrocytomaBrain TumorGlioblastomaNCT01082926City of Hope Medical Center6
招募中
1 期
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell TransplantMixed Phenotype Acute LeukemiaChronic Myelomonocytic LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeRecurrent Acute Biphenotypic LeukemiaRecurrent Acute Undifferentiated LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRefractory Acute Lymphoblastic LeukemiaRefractory Adult Acute Lymphoblastic LeukemiaRecurrent Blastic Plasmacytoid Dendritic Cell NeoplasmRecurrent Myelodysplastic SyndromeRefractory Blastic Plasmacytoid Dendritic Cell NeoplasmRefractory Myelodysplastic SyndromeRecurrent Acute Lymphoblastic LeukemiaRecurrent Acute Myeloid LeukemiaJuvenile Myelomonocytic LeukemiaAcute Undifferentiated LeukemiaMinimal Residual DiseaseAcute Biphenotypic LeukemiaChronic Myeloid LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Mixed Phenotype Acute LeukemiaLeukemiaAcute Myeloid LeukemiaLeukemiaJuvenile Myelomonocytic LeukemiaRecurrent Acute Biphenotypic LeukemiaRecurrent Acute Undifferentiated LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRefractory Acute Lymphoblastic LeukemiaRefractory Adult Acute Lymphoblastic LeukemiaBlast Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveRecurrent Blastic Plasmacytoid Dendritic Cell NeoplasmRecurrent Myelodysplastic SyndromeRefractory Blastic Plasmacytoid Dendritic Cell NeoplasmRefractory Myelodysplastic SyndromeAcute Undifferentiated LeukemiaRecurrent Chronic Myeloid Leukemia, BCR-ABL1 PositiveRefractory Chronic Myeloid Leukemia, BCR-ABL1 PositiveRecurrent Acute Lymphoblastic LeukemiaRecurrent Acute Myeloid LeukemiaChronic Myeloid LeukemiaAcute Biphenotypic LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Mixed Phenotype Acute LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeChronic Myelomonocytic LeukemiaMinimal Residual DiseaseMixed Phenotype Acute LeukemiaNCT03326921Fred Hutchinson Cancer Center24
已完成
1 期
Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Stage IV MelanomaRecurrent MelanomaStage IV MelanomaNCT00438984Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium11
已完成
2 期
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00331526Hoag Memorial Hospital Presbyterian83