EUCTR2008-002983-32-BE进行中（未招募）1 期
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
- 1 期
- 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
- •Stratum A Specific Inclusion Criterion:
- •Refractory AML with confirmed initial diagnosis of de novo AML (excluding
- •Stratum B Specific Inclusion Criterion:
- •Refractory AML with confirmed initial diagnosis of AML (excluding APL)
- •secondary to precedent AHD or MDS with either condition being diagnosed
- •at least three months before confirmed diagnosis of AML . [Patients may
- •have received no prior treatment or treatment with conventional care
- •regimens, including best supportive care , low dose cytarabine, intensive
- •chemotherapy, hypomethylating agents (azacitidine, decitabine), or other
- •therapies (e.g. lenalidomide)] for precedent MDS/AHD.
- •Stratum A or B General Inclusion Criteria:
- •1. Written informed consent prior to study-specific screening procedures.
- •2. Age = 18 years old
- •3. Patients with refractory AML (according to Estey 1996b)], whose
- •is primary refractory (= no complete remission following initial
- •induction therapy), OR
- •has relapsed within 12 months after CR1 and for whom salvage (reinduction)
- •chemotherapy is not indicated for documented clinical
- •reasons OR documented patient refusal OR
- •has relapsed within 12 months after CR1 and patient has failed
- •one salvage (re-induction) (Failure or relapse after CR2)
- •4. Eastern Cooperative Group (ECOG) performance status = 2
- •5. Laboratory values defined as follows:
- •Electrolyte panel WNL for the institution (potassium and magnesium
- •values < lower limit of normal must be corrected to WNL prior to
- •Total calcium (corrected for serum 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 (NCI CTCAE Gr 1) unless attributed to
- •underlying disease
- •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 a minimum of one and a maximum of three
- •administrations of conventional remission induction therapy (this may
- •include consolidation and/or HSCT) for newly diagnosed AML.
- •7. Previous therapy 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 AML treatment, including
- •= Gr 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)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- 另有 1 项未显示
排除标准
- •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 precedent
- •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 graft versus host
- •(GVH) directed therapy
- •5. Patients who have received either hydroxyurea or glucocorticosteroids
- •for prevention of leukostasis less than 24 hours before the first dose of
- •6. Patients with another malignancy (with the exception of prior MDS for
- •secondary AML patients in Stratum B) 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 completed
- •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 bpm), QTcF = 450 ms on screening ECG, or right bundle
- •branch block + left anterior hemiblock (bifascicular block)
- •LVEF < lower limit of institutional normal, as assessed by ECHO or
- •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 myocardial infarction (MI) within 6 months
- •Other clinically significant heart disease (e.g. uncontrolled
- •hypertension or history of poor compliance with a antihypertensive
- •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
- •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
- •10. Psychiatric disorder that interferes with ability to understand the study
- •and give informed consent, and/or would impact study participation or
- •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
- 另有 2 项未显示
研究者
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