G-CSF and Plerixafor With Sorafenib for Acute Myelogenous Leukemia With FLT3 Mutations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Sorafenib
研究概览
简要总结
The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AML. The safety of this combination will also be studied.
Funding Source - FDA OOPD
详细描述
The Study Drugs:
Sorafenib is a type of drug called a multikinase inhibitor. It is designed to interfere with the parts of cancer cells that are involved in the sending of chemical messages and helping the cells divide and grow, which may block the formation of tumors and cause cell death.
Filgrastim promotes the growth of white blood cells, which help to fight infections.
Plerixafor is designed to help move stem cells from the bone marrow to the blood.
Study Drug Dose Level:
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
- •Patients will be 18 years of age or older.
- •Patients must have relapsed/refractory leukemia with FLT3 (ITD) mutations. Patients with AML FLT3 mutations who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible.
- •Serum biochemical values with the following limits unless considered due to leukemia: creatinine </= 1.5 mg/dl; total bilirubin </= 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder; or transaminases (SGPT) </= 2.5 x upper limit of normal (ULN)
- •Able to take oral medication.
- •Able to understand and provide signed informed consent.
- •Ejection fraction at screening must be >/=50%.
- •Performance status < 3, unless directly related to leukemic disease process as determined by the Principal Investigator.
排除标准
- •Subjects with acute promyelocytic leukemia.
- •Patients with absolute blast count > 20 k/uL.
- •Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
- •Men not willing to maintain adequate contraception with their partner over the entire course of the study.
- •Hypertension > 140 mmHg systolic OR > 90 mmHg diastolic with or without antihypertensive therapy.
- •Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- •Known human immunodeficiency virus (HIV) infection or active Hepatitis B or C.
- •Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •Pulmonary hemorrhage/bleeding event >/= CTCAE Grade 2 within 4 weeks of first dose of study drug.
- •Any other hemorrhage/bleeding event >/= CTCAE Grade 3 within 4 weeks of first dose of study drug.
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- •Currently using St. John's Wort or rifampin.
- •Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- •Active clinically serious and uncontrolled infection > CTCAE Grade
- •Serious non-healing wound, ulcer, or bone fracture.
- •Patients currently receiving any other standard or investigational treatment for their hematologic malignancy.
研究组 & 干预措施
G-CSF and Plerixafor with Sorafenib
G-CSF 10 mcg/kg adjusted body weight subcutaneous injection. Plerixafor fixed dose of 240 mcg/kg adjusted body weight subcutaneous injection in abdomen. Patients will receive the 1st doses of G-CSF and Plerixafor on day 1. G-CSF and Plerixafor every other day for 7 total doses, repeated every 28 days. Sorafenib starting dose 400 mg twice daily orally after G-CSF/Plerixafor injections.
干预措施: G-CSF (Drug)
G-CSF and Plerixafor with Sorafenib
G-CSF 10 mcg/kg adjusted body weight subcutaneous injection. Plerixafor fixed dose of 240 mcg/kg adjusted body weight subcutaneous injection in abdomen. Patients will receive the 1st doses of G-CSF and Plerixafor on day 1. G-CSF and Plerixafor every other day for 7 total doses, repeated every 28 days. Sorafenib starting dose 400 mg twice daily orally after G-CSF/Plerixafor injections.
干预措施: Plerixafor (Drug)
G-CSF and Plerixafor with Sorafenib
G-CSF 10 mcg/kg adjusted body weight subcutaneous injection. Plerixafor fixed dose of 240 mcg/kg adjusted body weight subcutaneous injection in abdomen. Patients will receive the 1st doses of G-CSF and Plerixafor on day 1. G-CSF and Plerixafor every other day for 7 total doses, repeated every 28 days. Sorafenib starting dose 400 mg twice daily orally after G-CSF/Plerixafor injections.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Sorafenib
时间窗: Participant toxicity rates evaluated at 8 weeks of treatment (2 cycles)
MTD dose level of Sorafenib where less than two participants (2/3) experience Dose limiting toxicity (DLT), based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, is defined as ± Grade 3 nonhematological toxicity or nausea/vomiting (in the absence of appropriate antiemetics) that cannot be explained by intercurrent conditions such as infections and at least possibly related to the combination of agents in study.
次要结局
未报告次要终点