NCT03945591已完成2 期
A Phase II Study of High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Experience Acute GvHD
研究概览
简要总结
This is a single arm open label phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from matched-related or unrelated donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity or myeloablative conditioning regimen of fludarabine, busulfan, and rabbit anti-thymocyte globulin (rATG). Patients will receive PTCyBor as GvHD 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky score ≥ 70%
- •No evidence of progressive bacterial, viral, or fungal infection
- •Creatinine clearance > 50 mL/min/1.72m2
- •Total bilirubin, ALT and AST < 2 x the upper limit of normal (except for Gilbert's syndrome)
- •Alkaline phosphatase ≤ 250 IU/L
- •Left Ventricular Ejection Fraction (LVEF) > 45%
- •Adjusted Carbon Monoxide Diffusing Capacity (DLCO) > 60%
- •Negative HIV serology
- •Negative pregnancy test: confirmation per negative serum β-human chorionic gonadotropin (β-hCG)
排除标准
- •Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from the first dose of bortezomib through 90 days after the last dose. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.
- •Male subjects who refuse to practice effective barrier contraception during the entire study treatment period and through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy).
- •Inability to provide informed consent.
- •Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix E), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
- •Known allergies to any of the components of the investigational treatment regimen.
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
- •Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
- •Prisoners
研究组 & 干预措施
Cyclophosphamide and Bortezomib
Experimental
干预措施: Bortezomib (Drug)
Cyclophosphamide and Bortezomib
Experimental
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Percentage of Participants Who Experience Acute GvHD
时间窗: Day 120 Post-Transplant
Rate of acute GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis.
Percentage of Participants Who Experience Moderate to Severe Chronic GvHD
时间窗: Day 365 Post-Transplant
Rate of chronic GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis.
次要结局
- Incidence of Primary Graft Failure(Day 45 Post-Transplant)
- Incidence of Poor Graft Function(Day 30 Post-Transplant)
- Incidence of Secondary Graft Failure(Day 730 Post-Transplant)
- Graft Versus Host Disease Relapse Free Survival (GRFS)(Day 730 Post-Transplant)
- Treatment Related Mortality (TRM)(Day 730 Post-Transplant)
- Relapse Rate (RR)(Day 730 Post-Transplant)
- Overall Survival (OS)(Day 730 Post-Transplant)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)Graft-versus-host DiseaseNCT05289167Northwell Health74
已完成
1 期
Cyclophosphamide, Abatacept, and Tacrolimus for GvHD PreventionGraft-versus-host DiseaseNCT04503616NYU Langone Health46
撤回
1 期
High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHDBone Marrow Transplant ComplicationsAcute Lymphoblastic Leukemia, AdultMyelodysplastic SyndromesChronic Myelomonocytic LeukemiaAcute Myeloid LeukemiaNCT05895201Indiana University
已完成
2 期
Hematopoietic Stem Cell Transplant for Fanconi AnemiaFanconi AnemiaNCT01071239Medical College of Wisconsin1
已完成
2 期
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell TransplantChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaChronic Myelogenous Leukemia, BCR-ABL1 PositiveDiffuse Large B-Cell LymphomaGraft Versus Host DiseaseMarginal Zone LymphomaMyeloproliferative NeoplasmRecurrent Acute Myeloid Leukemia With Myelodysplasia-Related ChangesRecurrent Plasma Cell MyelomaRefractory Plasma Cell MyelomaSecondary Myelodysplastic SyndromeHodgkin LymphomaMyelodysplastic SyndromeMantle Cell LymphomaFollicular LymphomaAcute LeukemiaNCT03128359City of Hope Medical Center38