EUCTR2017-001178-41-GB进行中（未招募）1 期
A Phase 2, Randomized, Biomarker-driven, Clinical Study in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with an Exploratory Arm in Patients with Newly Diagnosed High-Risk AML and ExploratoryArms with Varying Levels of MCL-1 Dependence
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
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
- •During Prescreening:
- •1.Be between the ages of =18 and =65 years
- •2.Have an established, pathologically confirmed diagnoses of AML by World Health Organization (WHO) criteria excluding acute promyelocytic leukemia (APL-M3) with a bone marrow of >5% blasts based on histology or flow cytometry
- •3.Be in first relapse (within 24 months of CR) or have primary refractory AML (no CR or CRi after 2 cycles of intensive anthracycline/cytarabine ± etoposide or cladribine induction) or have NDHR AML as defined in this protocol (see Section 4.4.4)
- •4.Demonstrate MCL-1 dependence of =40% by mitochondrial profiling in bone marrow, 30 - <40% for MCL-1 Dependency Exploratory Arm A, 15% - <30% (MCL 1 Dependency Exploratory Arm B), or 0 - <15% (MCL-1 Dependency Exploratory Arm C).
- •During Screening:
- •5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) =2
- •6. Have a serum creatinine level =1.8 mg/dL
- •7. Have an alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level =5 times upper limit of normal (ULN)
- •8. Have a total bilirubin level =2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)
- •9. Have a left ventricular ejection fraction (LVEF) >45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
- •10. Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate during and for 6 months after completion of study therapy.
- •11. Be able to comply with the requirements of the entire study.
- •12. Provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)
- •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 209
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Received more than 2 cycles of induction therapy for AML. Investigational agents as part of front-line therapy for AML may by acceptable following discussion with the Medical Monitor. Hydroxyurea is permitted (see #5 below).
- •2. Received any previous treatment with alvocidib or any other CDK inhibitor
- •3. Received a hematopoietic stem cell transplant within the previous 2 months
- •4. Have clinically significant graft versus host disease (GVHD), or GVHD requiring initiation or escalation of treatment within the last 21 days
- •5. Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting treatment on either arm.
- •6. Received >360 mg/m2 equivalents of daunorubicin
- •7. Have a peripheral blast count of >30,000/mm3 (may use hydroxyurea as in #5 above)
- •8. Received antileukemic therapy within the last 3 weeks (with the exception of hydroxyurea or if the patient has definite refractory disease). Refractory patients who received therapy within the last 3 weeks may be eligible with prior approval of the Medical Monitor.
- •9. Diagnosed with acute promyelocytic leukemia (APL, M3)
- •10. Have active central nervous system (CNS) leukemia
- •11. Have evidence of uncontrolled disseminated intravascular coagulation
- •12. Have an active, uncontrolled infection
- •13. Have other life-threatening illness
- •14. Have other active malignancies or diagnosed with other malignancies within the last 6 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- •15. Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
- •16. Are pregnant and/or nursing.
- •17. Have received any live vaccine within 14 days prior to first study drug administration.
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