EUCTR2008-002986-30-FR进行中（未招募）不适用
A phase Ib, open-label, multi-center dose-finding study of oral panobinostat (LBH589) in combination with ara-C and mitoxantrone as salvage therapy for refractory or relapsed acute myeloid leukemia - N/A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
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
- •Patients with cytopathologically confirmed diagnosis of AML according to
- •WHO criteria
- •Relapsed after receiving up to 1 prior induction regimens (first relapse) or
- •patients who are refractory (no CR) to not more than one prior combination
- •chemotherapy induction regimen.
- •Age more than 18 years
- •ECOG performance status = 2
- •Patients must have the following laboratory values unless considered due to
- •leukemia: AST/SGOT and/or ALT/SGPT = 2.5 x ULN; Serum creatinine = 1.5
- •x ULN or GFR = 60 mL/min; Total and direct serum bilirubin = 1.5 x ULN;
- •electrolyte panel within normal ranges for the institution unless attributed to
- •the underlying disease.
- •Eligible for ara-C and mitoxantrone chemotherapy
- •Written informed consent obtained prior to any screening procedures
- •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
- •Subjects with Acute Promyelocytic Leukemia (APL)
- •Concurrent therapy with any other investigational agent
- •Patients who received more than maximal two chemotherapy induction cycles
- •and four chemotherapy consolidation cycles for their AML disease
- •CNS involvement
- •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.
- •Male patients whose sexual partner(s) are women of childbearing potential
- •who are not willing to use a double barrier method of contraception, one of
- •which includes a condom, during the study and for 3 months after the end of
- •Prior treatment with deacetylase inhibitors
- •Patients who have received cumulative doses of = 360 mg/m2 of doxorubicin
- •(or its equivalent to other anthracyclines, e.g. 225 mg/m2 of idarubicin, 900
- •mg/m2 of daunorubicin, 140 mg/m2 of mitoxantrone, 450 mg/m2 of pegylated
- •liposomal doxorubicin hydrochloride).
- •Any of concurrent severe and/or uncontrolled medical conditions which could
- •compromise participation in the study. For example:
- •Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular
- •tachyarrhythmia, clinically significant resting bradycardia (<50 beats per
- •minute), QTcF > 460 ms on screening ECG, or right bundle branch block +
- •left anterior hemiblock (bifascicular block)
- •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
- •Previous history of angina pectoris or acute MI within 6 months
- •Baseline LVEF <45% by echocardiography
- •Other clinically significant heart disease (e.g. uncontrolled hypertension or
- •history of poor compliance with an antihypertensive regimen)
- •Uncontrolled diabetes
- •Active or uncontrolled infection
- •Uncontrolled hypothyroidism
- •Acute or chronic liver or renal disease
- •Impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter the absorption of oral panobinostat (e.g., ulcerative
- •diseases, diarrhea, malabsorption syndrome, or small bowel resection)
- •Time windows for prior therapies:
- •All acute toxic effects of any prior therapy of leukemic disease must have
- •resolved to National Cancer Institute (NCI) Common Terminology Criteria for
- •Adverse Events (CTCAE, Version 3.0) Grade <2 (with exception of
- •chemotherapy-induced alopecia)
- •Last dose of prior chemotherapy, immunotherapy or investigational agent no
- •less than 14 days prior to receipt of study medication and have recovered at
- •least CTCAE Grade <2, except for hydroxyurea which must be finished 48
- •hours before first administration.
- •Wide field radiotherapy = 4 weeks or limited radiation for palliation = 2 weeks
- •prior to starting the study treatment or who have not recovered from side
- •effects of such therapy
- •Drugs which may cause QT prolongation and the treatment cannot be
- 另有 5 项未显示
研究者
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