EUCTR2008-006799-32-NL进行中（未招募）不适用
The OPAL Study: A Phase II Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tosedostat (CHR-2797) in Elderly Subjects with Treatment Refractory or Relapsed Acute Myeloid Leukemia - OPAL study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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 prior to any study specific procedure.
- •2. Subjects with a confirmed diagnosis of AML according to WHO classification
- •(excluding acute promyelocytic leukemia [APL]) who have had either a first CR lasting
- •less than 12 months, or have not had a first CR and who will receive their first salvage therapy in this study [6]. For the purposes of this study, the following considerations apply:
- •Subjects may have received one induction course comprised of one or two cycles
- •provided both were with the same agents even if different doses were used.
- •Induction cycles should normally use agents and doses considered as standard of care for induction at the investigational site concerned. An induction cycle would
- •normally require at least part of the induction regimen to consist of approved agents.
- •An induction regimen comprised only of low dose chemotherapy would not normally
- •be considered suitable.
- •Subjects may have received consolidation for any number of cycles. Consolidation will be considered as any regimens given while the subject was in remission after 1-2 induction cycles.
- •Subjects who received hematopoietic stem cell transplant (HSCT) in first remission are eligible provided there has been no chemotherapy or other targeted therapies to treat a relapse. Donor leukocyte infusion (DLI) is allowed provided there is no evidence of hematologic relapse as defined by the International Working Group (IWG).
- •3. Subjects should have recovered from the adverse effects of prior therapies to grade =1 (according to CTCAE v3) (excluding alopecia and any adverse effects that are expected to be chronic & stable).
- •4. Subjects should have not received prior therapy for first relapse or for refractory disease (a second induction cycle is allowed as defined above).
- •5. Subjects must have bone marrow aspiration performed within four weeks prior to study entry showing the subject is neither a CR nor CRp. This may be done at the Screening visit if appropriate and feasible.
- •6. Subjects must have adequate hepatic and renal function including the following:
- •Total bilirubin = 1.5 x upper limit of normal.
- •AST and ALT = 2.5 x upper limit of normal.
- •Serum creatinine = 1.5 x upper limit of normal.
- •7. Age = 65 years.
- •8. Performance status (PS) = 2 (ECOG scale).
- •9. Screening left ventricular ejection fraction (LVEF) = 50%
- •10. Subject is able to comply with all study procedures during the study including all visits and tests.
- •11. Male subjects with female partners of reproductive potential must use acceptable
- •contraceptive methods for the duration of time on study and continue to do so for a
- •further 3 months after the end of tosedostat treatment.
- •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
- •1. Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy,
- •immunotherapy or use of any other investigational agents within 2 weeks prior to trial entry (with the exception of hydroxyurea which can be used in certain circumstances).
- •2. Subjects with APL (FAB type M3) or CML in blast crisis.
- •3. Any co-existing medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study.
- •4. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures.
- •5. Significant* cardiovascular disease defined as:
- •Congestive heart failure NYHA class 4
- •Unstable angina pectoris
- •History of myocardial infarction within 6 months prior to study entry
- •Presence of clinically significant valvular heart disease
- •Uncontrolled or clinically significant ventricular arrhythmia
- •Presence of clinically significant conduction defect on screening ECG
- •Uncontrolled hypertension (i.e., systolic BP >160mmHg, diastolic >90 mmHg in
- •repeated measurements) despite adequate therapy
- •Clinically significant atrial fibrillation.
- •*Grade 3/4 in the NCI CTCv3.0 grading would generally be considered clinically
- •significant, although this remains a judgment for the Investigator to make.
- •6. Gastrointestinal disorders that may interfere with absorption of drug.
- •7. Clinically significant interstitial lung disease.
- •8. Subjects with grade III–IV peripheral neuropathy [or central nervous system leukemia].
研究者
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