NCT01969435已完成2 期
A Phase II Study of Melphalan HCl for Injection (Propylene Glycol-free), Combined With Carmustine, Etoposide, and Cytarabine (BEAM Regimen) for Myeloablative Conditioning in Lymphoma Patients Undergoing Autologous Stem Cell Transplantation
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
- 50
- 试验地点
- 1
- 主要终点
- Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
研究概览
简要总结
Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma.
- •Eligible for autologous stem cell transplantation.
- •18 to 75 years of age at time of enrollment.
- •Adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 x 10^6 CD34+ cells/kg based on patient body weight
- •ECOG performance status ≤ 2
- •Normal organ function as defined below:
- •Creatinine clearance > 40 ml/min
- •Total bilirubin ≤2.0 x IULN
- •AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- •LVEF > 40% (by ECHO or MUGA)
- •FEV1 > 50% of predicted and DLCO > or = 50% of predicted
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Able to understand and willing to sign an IRB approved written informed consent document.
排除标准
- •A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- •Currently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollment.
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan HCl for injection (propylene glycol-free), Captisol, or other agents used in the study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant and/or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
- •Known HIV-positivity. These patients are excluded because of the potential for pharmacokinetic interactions with the study regimen and their antiretroviral therapy and because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. .
研究组 & 干预措施
Melphalan, carmustine, etoposide, cytarabine (BEAM)
Experimental
- Day -7, carmustine intravenous (IV) infusion
- Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
- Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
- Day 0, stem cell transplant.
干预措施: Carmustine (Drug)
Melphalan, carmustine, etoposide, cytarabine (BEAM)
Experimental
- Day -7, carmustine intravenous (IV) infusion
- Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
- Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
- Day 0, stem cell transplant.
干预措施: Etoposide phosphate (Drug)
Melphalan, carmustine, etoposide, cytarabine (BEAM)
Experimental
- Day -7, carmustine intravenous (IV) infusion
- Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
- Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
- Day 0, stem cell transplant.
干预措施: Cytarabine (Drug)
Melphalan, carmustine, etoposide, cytarabine (BEAM)
Experimental
- Day -7, carmustine intravenous (IV) infusion
- Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
- Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
- Day 0, stem cell transplant.
干预措施: Melphalan HCl (propylene glycol-free) (Drug)
结局指标
主要结局
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
时间窗: Day -7 through Day 30
Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.
Treatment-related Mortality (TRM)
时间窗: 100 days
TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant
次要结局
- Efficacy as Measured by Response Rates(Up to Day 100)
- Disease-free Survival(2 years)
- Time to Engraftment (Neutrophil)(Assessed up to day 30)
- Time to Engraftment (Platelet)(Assessed up to day 100)
研究者
研究点 (1)
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