Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.
研究概览
简要总结
The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (>0.5 x 10^9/L for 3 consecutive days), and platelet (>20X 10^9/L for 3 consecutive days).
The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age > =18 who have been diagnosed with Multiple Myeloma and are scheduled for autologous peripheral blood hematopoietic stem cell transplant (AHSCT) will be screened for eligibility.
- •Patients must fulfill all of the following inclusion criteria to be eligible for this study:
- •Diagnosis of Multiple Myeloma
- •Age >=18 and no more than 70 years.
- •Able to understand and sign a consent form.
- •Can collect peripheral blood stem cells with a CD34+ cell dose of at least 5.0 x 106/kg. The CD34 molecule is a Cluster of Differentiation molecule present on hematopoietic stem cells.
- •Conditioning regimen to be high dose Melphalan at a dose of 200mg/m
- •Karnofsky Performance Score (KPS) >60 or ECOG (Eastern Cooperative Oncology Group) performance status <=2
- •Kidney function:Creatinine <2.0 mg/dl or creatinine clearance >50 ml/min
- •Heart function: Ejection fraction >45%
- •Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
- •Lung function tests: Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >45% predicted
排除标准
- •Age <18 years or > 70 years
- •Previous exposure to denileukin diftitox.
- •Patients with documented uncontrolled central nervous system (CNS) disease.
- •Previous AHSCT.
- •Significant organ dysfunction deemed to be inappropriate for autologous transplantation.
研究组 & 干预措施
Denileukin Diftitox (Ontak)
Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
干预措施: Denileukin Diftitox (Ontak) (Drug)
结局指标
主要结局
Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.
时间窗: Up to 21 days post transplant
After drug infusion, participants will be closely monitored for at least 4 hours for side effects
次要结局
- To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.(days 0 and 21 post autologous stem cell transplantation)
- To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose.(days 0 and 21 post autologous stem cell transplantation)
- To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose.(days 0 and 21 post autologous stem cell transplantation)
研究者
Zaid Al-Kadhimi
Principal Investigator
Barbara Ann Karmanos Cancer Institute