A Multicenter Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The Percent of Subjects Engrafting by Day +30 After Transplantation
研究概览
简要总结
The main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant).
详细描述
Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being used in adults more often. However, because adults are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults and engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have one of the following disease types:
- •Acute myeloid leukemia (AML) with disease features as described in the protocol.
- •Acute lymphoblastic leukemia (ALL) with disease features as described in the protocol.
- •Myelodysplasia with disease features as described in the protocol.
- •Chronic myelogenous leukemia (CML) with disease features as described in the protocol.
- •Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the disease features as described in the protocol.
- •At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy.
- •For patients in remission, there should be no readily available consenting HLA-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB
- •No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1).
- •Patients must have a matched or partially matched UCB unit with >/= 2.5 x10^7 nucleated cells/kg of recipient weight at the time of cryopreservation.
- •No current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms).
- •No HIV disease.
- •Non pregnant and non-nursing.
- •Required baseline laboratory values as described in the protocol.
- •Signed written informed consent.
排除标准
- •Symptomatic uncontrolled coronary artery disease or congestive heart failure.
- •Severe hypoxemia with room air PaO2<70, supplemental oxygen dependence, or DLCO<50% predicted.
- •Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy.
- •Prior allogeneic or autologous hematopoietic stem cell transplant in the last 6 months.
- •Patients who are taking other insulin secretagogues and/or insulin.
- •Patients who have hypersensitivity to sitagliptin.
- •Patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting hypertriglyceridemia (> 2 x ULN).
研究组 & 干预措施
Sitagliptin
Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
干预措施: Sitagliptin (Drug)
结局指标
主要结局
The Percent of Subjects Engrafting by Day +30 After Transplantation
时间窗: Day 0 to Day +30 post transplant
Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.
次要结局
- Time to Neutrophil Engraftment(Transplant (Day 0) up to 1 year)
- Time to Platelet Engraftment(Transplant (Day 0) up to 1 year)
- Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities(Day 0 up to 3 years)
研究者
Sherif S. Farag
Lawrence H. Einhorn Professor of Oncology
Indiana University