Optimized CBT for Pts With High-risk Hematologic Malignancies Who Have Relapsed After First ASCT
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.
详细描述
Primary Objective:
To evaluate 1-year overall survival (OS) following CBT with intermediate dose intensity conditioning for patients in need of a second allogeneic stem cell transplantation.
Secondary Objectives:
Speed and success of neutrophil and platelet engraftment. Incidences of graft failure.
• Incidence of day 100 grade II-IV and III-IV aGVHD and day 180 grades II-IV and III-IV aGVHD.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.
- •Patient must have relapsed >100 days since first transplant.
- •Diagnosis and Disease Status:
- •a. Acute myelogenous leukemia (AML): i. Patients in morphologic remission (<5% blasts) at the time of transplant, with or without persistent cytogenetic, flow cytometric, or molecular aberrations, or those with hypocellular marrows at time of transplant, are eligible. b. Acute lymphoblastic leukemia (ALL): i. Patients in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those or who have hypocellular bone marrows, are eligible. c. Other acute leukemias: i. Acute leukemias of ambiguous lineage or mixed phenotype in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those who have hypocellular bone marrows, are eligible. d. Myelodysplastic Syndromes (MDS) or CMML without myelofibrosis. i. Includes MDS with any IPSS risk category.
- •Prior treatment:
- •a. To be eligible for this study, patients need to have received one prior allogeneic stem cell transplantation.
- •Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).
- •Renal and Liver function:
- •Calculated creatinine clearance > 50 ml/min.
- •Bilirubin < 2 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).
- •ALT < 5 x upper limit of normal (ULN).
- •Pulmonary function: Spirometry corrected DLCO ≥ 60% predicted. This criteria is waived for patients who are developmentally unable to complete pulmonary function test.
- •Left ventricular ejection fraction (MOD-bp) > 50%.
- •Graft Criteria:
- •Two CB units will be selected according to the current MDACC CB unit selection algorithm.
- •High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed.
- •Unit selection will occur based on HLA-match, total nucleated cell (TNC), and CD34+ cell dose adjusted per patient body weight.
- •The bank of origin will also be considered.
- •Donor-specific HLA antibodies, if present, will also be taken into consideration.
- •Each CB unit must be at least 3/8 HLA-matched to the patient considering high-resolution 8-allele HLA typing.
- •Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 107 TNC/ recipient body weight (TNC/ kg).
- •Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.0 x 105 CD34+ cells/ recipient body weight (CD34+ cells/kg).
- •A minimum of one unit will be reserved as a backup graft.
- •Each CB unit will be required to be cryopreserved in standard cryovolume. (24- 27 ml/s per unit) and be red blood cell depleted.
排除标准
- 未提供
研究组 & 干预措施
Optimized CBT
Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service.
干预措施: Fludarabine (Drug)
Optimized CBT
Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service.
干预措施: Drugs Cyclophosphamide (Drug)
Optimized CBT
Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service.
干预措施: Mycophenolate mofetil (Drug)
Optimized CBT
Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service.
干预措施: Tacrolimus (Drug)
Optimized CBT
Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service.
干预措施: Thiotepa (Drug)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点