Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- determine if this target AUC can be achieved
研究概览
简要总结
The purpose of this study is to find out whether it is practical to use a newer way to calculate melphalan dose given (called population PK model) in BEAM chemotherapy before AHCT. Standard dose is fixed for everybody and is calculated using height and weight. The population PK model, tested in this study, uses information based on people who have previously received melphalan and aims to calculate an optimal dose separately for each person. Study researchers think that the dose calculated using the population PK model may still be effective but have less side effects than the standard melphalan dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Age18 - 79 years old
- •Diagnosed with any type of lymphoma [Hodgkin, non-Hodgkin (B- or T-cell)] and planned for BEAM-AHCT
- •KPS > 70
- •Cardiac ejection fraction of > 45%
- •Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
- •Creatinine clearance of ≥ 40 mL/min
- •Completion of most recent systemic therapy within 12 weeks of enrollment
- •Complete or partial response to systemic chemotherapy by IWG Working Group Criteria.
- •Total bilirubin < 2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST & ALT < 2.5 ULN.
- •Minimum stem cell dose of 2 x 10*6 CD34+ cells/kg
排除标准
- •Disease progression by IWG Working Group since last therapy
- •Pregnant or lactating females
- •Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim
- •Any known allergy or allergic reactions to Captisol
- •Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
研究组 & 干预措施
Cohort 1: Pharmacokinetic directed melphalan
This is a feasibility study of pharmacokinetic (PK)-directed Captisol Enabled (CE) melphalan dosing to target an AUC of 8.5 (+/- 1.5) using a population PK model in lymphoma patients receiving BEAM [carmustine (BCNU) (B), etoposide (E), cytarabine (Ara-C) (A), and melphalan (M)], followed by autologous hematopoietic cell transplantation (AHCT). This study will enroll patients with lymphoma planned for BEAM-AHCT. Carmustine IV will be given on day -6, followed by etoposide IV and cytarabine IV from day -5 to -2 as per the MSK inpatient or outpatient standard of care. The calculated melphalan dose based on population PK model to achieve the proposed melphalan target exposure [8.5 (+/- 1.5) mg*h/L], will be administered on day -1, and six peripheral blood samples of 5 ml in lithium heparin tubes will be collected at 5, 15, 30, 40, 75, and 150 minutes after the melphalan, for PK testing to determine if the goal AUC was achieved.
干预措施: Pharmacokinetics (Other)
Cohort 2: Pharmacokinetic directed melphalan
In cohort 2, carmustine will be on Day -7, cytrabine and etoposide on Day -6 to Day -3, and melphalan (70mg/m2 /day IV) will be administered on day -2 followed by PK samples to determine the melphalan dose on day -1 using the population PK model. PK samples will be collected again after the dose on day -1 to confirm the total melphalan AUC of 8.5 (+/- 1.5) mg*h/L. Six peripheral blood samples of 5 ml in lithium heparin tubes will be collected at 5, 15, 30, 40, 75, and 150 minutes after the melphalan, for PK testing. The first four time points are +/- 2 min and the last two time points are +/- 5 minutes.
干预措施: Pharmacokinetics (Other)
结局指标
主要结局
determine if this target AUC can be achieved
时间窗: 1 year
within a range of 8.5 (+/- 1.5) mg\*h/L using population PK model.
次要结局
未报告次要终点