EUCTR2008-002983-32-GR进行中（未招募）不适用
A Phase II Study of Oral Single Agent Panobinostat in Patients with Refractory de novo or secondary Acute Myelogenous Leukemia (AML) - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 164
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
- •5.1.1 Stratum A Specific Inclusion Criterion
- •1. Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL)
- •5.1.2 Stratum B Specific Inclusion Criterion
- •Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to
- •AHD or MDS with either condition precedent to AML (MDS/AHD) having received either no
- •treatment or conventional care regimens (CCR), including best supportive care (BSC), low
- •dose cytarabine, intensive chemotherapy, hypomethylating agents (azacitidine, decitabine), or
- •other therapies (e.g. lenalidomide)
- •5.1.3 Stratum A or B General Inclusion Criteria
- •1. Written informed consent prior to study-specific screening procedures
- •2. Age = 18 years old
- •3. Refractory AML, defined as no response (CR1) to initial induction treatment or CR1
- •lasting <12 months and in first relapse
- •4. Eastern Cooperative Group (ECOG) performance status = 2
- •5. Laboratory values as follows:
- •Electrolyte panel WNL for the institution (potassium and magnesium values < lower
- •limit of normal must be corrected to WNL prior to dosing)
- •Total calsium (corrected for albumin) or ionized calcium WNL for the institution
- •AST/SGOT and ALT/SGPT = 2.5 x ULN (NCI CTCAE Gr 1)
- •Serum creatinine = 1.5 x ULN (NCI CTCAE Gr 1)
- •Serum bilirubin = 1.5 x ULN unless attributed to underlying disease (NCI CTCAE Gr
- •INR = 1.5 and PTT WNL. Patients receiving anticoagulation therapy (e.g. coumadin,
- •heparin) are eligible provided anticoagulation therapy can be discontinued or changed
- •to parenteral medications while the platelet count is less than 50,000/mm3
- •Negative serum pregnancy test (within 7 days of first dose)
- •Negative urine pregnancy test immediately prior to first dose
- •Clinically euthyroid (hypothyroidism corrected with supplementation is permitted)
- •6. Patient has received remission induction therapy (± consolidation) for AML, including
- •chemotherapy and/or HSCT.
- •7. Previous chemotherapy for AML has stopped at least 2 weeks or at least five half lives,
- •whichever is longer, before the first dose of study drug
- •8. Patient has recovered from toxicity of previous antileukemic therapy, including Grade = 1
- •non-hematologic toxicity prior to the first dose of study drug
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •5.1.4 Stratum A or B General Exclusion Criteria
- •1. Patients with initial diagnosis of AML secondary to ionizing radiation/cytotoxic therapy
- •(e.g. alkylating agents) for previous malignancy
- •2. Patients requiring valproic acid for any medical condition during the study or within 5
- •days prior to the first dose of study drug
- •3. Clinical symptoms suggesting CNS leukemia (patients with neurologic symptoms must
- •undergo lumbar puncture and a CT scan or MRI of the brain to exclude CNS involvement
- •4. Patients receiving supportive therapy related to complications of allogeneic
- •transplantation, including infections or GVH directed therapy
- •5. Patients who have received either hydroxyurea or glucocorticosteroids for prevention of
- •leukostasis less than 24 hours before the fist dose of study drug
- •6. Patients with another malignancy (with the exception of prior MDS in patients with initial
- •diagnosis of AML secondary to MDS/AHD) unless disease-free for at least 3 years
- •following the completion of curative intent therapy. Patients with treated non-melanoma
- •skin cancer, in situ carcinoma, or cervical intraepithelial neoplasm regardless of the
- •disease-free duration, are eligible if definitive treatment for the condition has been
- •7. Patients with impaired cardiac function including any of the following:
- •Complete left bundle branch block or use of a permanent cardiac pacemaker,
- •congenital long QT syndrome, history or presence of ventricular tachyarrhythmias,
- •clinically significant resting bradycardia (<50 beats per minute), QTcF = 450 ms on
- •screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular
- •LVEF< lower limit of institutional normal, as assessed by ECHO or MUGA
- •Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). Patients
- •with stable atrial fibrillation are eligible provided they do not meet the other cardiac
- •exclusion criteria
- •Angina pectoris or acute MI within 6 months
- •Other clinically significant heart disease (e.g. uncontrolled hypertension or history of
- •poor compliance with an antihypertensive regimen)
- •8. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled
- •diabetes mellitus, chronic obstructive or chronic restrictive pulmonary disease including
- •dyspnea at rest from any cause) or history of serious organ dysfunction or disease
- •involving the heart, kidney or liver and/or known seropositive HIV (HIV screening testing
- •is not required)
- •9. Patient has an impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter the absorption of oral panobinostat (e.g., ulcerative disease,
- •uncontrolled vomiting, grade > 1 diarrhea, malabsorption syndrome, obstruction, or
- •stomach and/or small bowel resection)
- •10. Psychiatric disorder that interferes with ability to understand the study and give informed
- •consent, and/or would impact study participation or follow-up
- •11. Concurrent use of medications that have a relative risk of prolonging the QT interval or of
- •inducing Torsade de Pointes, if such treatment cannot be discontinued or switched to a
- •different medication prior to the first dose of study drug
- •12. Female patients who are pregnant or breast-feeding or patients of childbearing potential
- •(WOCBP) not willing to use a double barrier method of contraception during the study
- •and for 3 months following the last dose of study drug. WOCBP are defined as sexually
- •mature women who have not undergone a hysterectomy or surgical sterilizat
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