EUCTR2014-002448-42-IE进行中（未招募）1 期
A Phase I/II, open-label multicenter study to determine safety, pharmacokinetics and efficacy of GMI-1271 in combination with chemotherapy in patients with acute myeloid leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent form (ICF)
- •2.AML (including secondary AML) diagnosed as per World Health Organization (WHO) criteria (Brunning RD 2001) as per local analysis report.
- •3.For relapsed/refractory subjects only:
- •a) Subjects age = 18 years
- •b) For subjects with primary refractory AML, = 2 prior induction regimens, at least one containing anthracyclines
- •c) For subjects with relapsed AML, first or second untreated relapse. Secondary refractory disease (e.g. refractory after first or second relapse) may not be included. Subjects with one prior HSCT may be included. Any cytotoxic induction regimen used with the intent to induce remission, regardless of the agents used, will be counted as an induction attempt towards this assessment. Single agent FLT3 inhibitors are not considered cytotoxic chemotherapy for the purposes of this
- •assessment.
- •d) Have not previously received MEC and are medically eligible to receive MEC
- •e) Absolute blast count (ABC) = 20,000/mm3 (ABC = total white blood cells [WBC] x blast %)
- •Entry ABC will be raised to = 40,000/mm3 after evaluation of first two dose levels
- •4.For treatment-naïve subjects only:
- •a) Subjects = 60 years of age with newly diagnosed AML
- •b) Medically eligible to receive 7+3” cytarabine/idarubicin
- •c) Absolute blast count (ABC) count = 40,000/mm3
- •5.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •6.Life expectancy > 4 weeks
- •7.Hemodynamically stable with adequate organ function
- •a)AST and ALT = 2.5 ULN
- •b)Bilirubin = 1.5 ULN
- •c)Creatinine = 1.5 ULN
- •d)QTcF = 480 ms
- •8.Willing and able to participate in all required evaluations and procedures in this study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •1.Acute promyelocytic leukemia
- •2.Acute leukemia of ambiguous lineage (biphenotypic leukemia)
- •3.Active signs or symptoms of CNS involvement by malignancy (LP not required)
- •4.Prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
- •5.Known history or evidence of active hepatitis A, B, or C or HIV
- •6.Uncontrolled acute life threatening bacterial, viral or fungal infection
- •7.Active graft versus host disease (GVHD) = Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
- •8.HSCT = 4 months of dosing
- •9.Any immunotherapy, radiotherapy or experimental therapy within 4 weeks of dosing; any chemotherapy within 14 days of dosing, with the exception of: hydroxyurea, which may be used to control peripheral blast count prior to initiation of GMI-1271 dosing; and FLT3 inhibitors or TKI inhibitors, which are not considered cytotoxic chemotherapy; to avoid any drug-drug interaction such agents must be discontinued 5 days before protocol treatment begins.
- •10.Major surgery within 4 weeks before first dose of study drug
- •11.Significant cardiovascular disease
- •12.Previous or concurrent malignancy
- •13.Pregnant or nursing (lactating) women
- •14.WOMEN of child-bearing potential unless they are using highly effective methods of contraception during the study
- •15.MEN who are sexually active and not willing to use condoms during the duration of the study unless they have undergone vasectomy for sterilization
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