EUCTR2015-001151-68-IT进行中（未招募）1 期
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia - APOLLO-TRIA
TECHNISCHE UNIVERSITäT DRESDE0 个研究点目标入组 280 人开始时间: 2019年2月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
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
- •- Informed consent
- •- newly diagnosed APL by cytomorphology, confirmed also by molecular analysis*
- •- Age =18 and = 65 years
- •- ECOG performance status 0-2
- •- WBC at diagnosis > 10 Gpt/l
- •- serum total bilirubin = 3.0 mg/dl (= 51 µmol/l)
- •- serum creatinine = 3.0 mg/dl (= 260 µmol/l)
- •- women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
- •oPost-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
- •oPostoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
- •oContinuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
- •oSexual abstinence
- •oVasectomy of the sexual partner
- •* The confirmation of diagnosis at genetic level (microspeckled PML nuclear distribution by PGM3 monoclonal antibody and/or PML/RARa fusion by RT-PCR or fluorescence in situ hybridization (FISH) and/or demonstration of t(15;17) at karyotyping) will be mandatory for patient eligibility. However, in order to avoid delay in treatment initiation, patients can be randomized on the basis of morphologic diagnosis only and before the results of genetic tests are available.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients who are not eligible for chemotherapy as per discretion of the treating physician
- •- Age <18 and > 65 years
- •- WBC at diagnosis = 10 Gpt/l
- •- APL secondary to previous radio- or chemotherapy for non-APL disease
- •- ECOG performance status >2
- •- other active malignancy at time of study entry
- •- lack of diagnostic confirmation at genetic level
- •- Significant arrhythmias, ECG abnormalities or neuropathy:
- •?Congenital long QT syndrome;
- •?History or presence of significant ventricular or atrial tachyarrhythmia;
- •?Clinically significant resting bradycardia (<50 beats per minute)
- •?QTc >500msec on screening ECG for both genders (using the QTcF formula detailed on page 43-44)
- •?Right bundle branch block plus left anterior hemiblock, bifascicular block
- •- other cardiac contraindications for intensive chemotherapy (L-VEF <50%)
- •- uncontrolled, life-threatening infections
- •- severe non controlled pulmonary or cardiac disease
- •-severe hepatic or renal dysfunction
- •- known HIV and/or hepatitis C infection
- •- pregnant or breast-feeding patients
- •- allergy to trial medication or excipients in study medication
- •- substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results
- •- use of other investigational drugs at the time of enrolment or within 30 days before study entry
研究者
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