NCT05421299已完成不适用
Overall Survival in 7/8 HLA-Matched Hematopoietic Stem Cell Transplantation Patients Treated With Abatacept Combined With a Calcineurin Inhibitor and Methotrexate- An Analysis of the Center for International Blood and Marrow Transplant Research (CIBMTR) Database
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2019年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy
研究概览
简要总结
The purpose of this study is to estimate overall survival (OS) for participants treated with abatacept versus those not treated with abatacept prior to hematopoietic stem cell transplantation (HSCT). Participants were included if their donors were unrelated and had 1-allele mismatched human leukocyte antigen (HLA) status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who underwent first allogenic transplant in the US
- •Participants with an unrelated donor who are HLA-matched at 7/8 loci (A, B, C, DRB1)
- •Participants at least 6 years old with weight at least 20 kilograms
- •Participants with a Karnofsky/Lansky Performance Score ≥80%
- •Participants whose first allogeneic transplant occurred from January 1, 2011 to December 31, 2018
- •Participants with any of the following diseases: AML, ALL, CML, MDS, HL, NHL
- •Participants with any of the following graft versus host disease (GVHD) prophylaxis treatments:
- •CNI plus MTX (with or without ATG and with or without abatacept); or
- •Post-transplant cyclophosphamide (PT-Cy) without antithymocyte globulin (ATG)
- •Participants treated with any of the following conditioning regiments: total body irradiation (TBI)/cyclophosphamide (Cy), busulfan (Bu)/Cy, Bu/fludarabine (flu), Flu/Melphalan (MEL)
排除标准
- •Participants with missing information on ATG (yes/no)
- •Participants receiving alemtuzumab (Campath)
- •Participants with cord blood grafts
- •Participants with non-MDS myeloproliferative disorders (NOTE: Participants with chronic myelomonocytic leukemia [CMMoL] will be included)
- •Participants who did not consent to participate in research
- •Participants treated at embargoed centers for research
- •Participants treated with abatacept and ATG
- •Among non-abatacept treated participants, participants transplanted at centers with abatacept trial participants
- •Participants with any of the following missing propensity score variables:
- •Disease status at transplantation (early, intermediate, advanced HL and NHL-chemosensitive)
- •Gender (male, female)
- •HSCT graft source (bone marrow [BM], peripheral blood [PB])
- •Conditioning intensity (myeloablative, non-myeloablative / reduced intensity)
- •Karnofsky/Lansky Performance Score (80%, 90-100%)
- •CNI type (tacrolimus, CsA)
结局指标
主要结局
Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy
时间窗: Up to 180 days post transplant
次要结局
- Overall Survival in Participants Treated with Study Therapy(Up to 180 days post transplant)
- Overall Survival in Participants Treated with Study Therapy Plus Tacrolimus(Up to 180 days post transplant)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumabadvanced hematological malignancyJPRN-UMIN000007913Division of Hematology, Saitama Medical Center, Jichi Medical University14
已完成
2 期
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic MalignanciesHematologic MalignancyNCT01341301Sidney Kimmel Cancer Center at Thomas Jefferson University25
终止
2 期
T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic TransplantJuvenile Myelomonocytic LeukemiaAcute Myelocytic LeukemiaChronic Myelocytic LeukemiaHodgkin or Non-Hodgkin LymphomaSarcoma, MyeloidAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeNCT01621477St. Jude Children's Research Hospital34
Unknown
不适用
Overall Survival and Disease-free Survival in Breast Cancer Patients Under COSBreast CancerNCT02745262IVI Vigo400
已完成
不适用
Partially Matched Stem Cell Transplantation for Patients With Refractory Severe Aplastic Anemia or Refractory CytopeniasAnemia, AplasticAmegakaryocytic ThrombocytopeniaDiamond-Blackfan AnemiaKostmann SyndromeNCT00244010St. Jude Children's Research Hospital4