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 patients with newly diagnosed, high-risk acute prOmyelocytic leukemia. - HOVON 138 AML / APOLLO

Technische Universität Dresden0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1.Informed consent
•2.Women or men with a newly diagnosed APL by cytomorphology, confirmed by molecular analysis
•3.Age >= 18 and <= 65 years
•4.ECOG performance status 0-3
•5.WBC at diagnosis > 10GPt/l
•6.Serum total bilirubin <= 3.0 mg/dl (<=51 µmol/l)
•7.Serum creatinine <= 3.0 mg/dl (<=260 µmol/l)
•8.Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
•a.Post-menopausal (12 months of natural amenorrhea or 6 months amenorrhea with serum FSH > 40 U/ml)
•b.Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
•c.Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device-IUD)
•d.Sexual abstinence
•e.Vasectomy of the sexual partner

•1.Patients who are not eligible for chemotherapy as per discretion of the treating physician
•2.APL secondary to previous radio- or chemotherapy for non-APL disease
•3.Other active malignancy at time of study entry (exception: basal-cell carcinoma)
•4.Lack of diagnostic confirmation at genetic level
•5.Significant arrhythmias, ECG abnormalities:
•a.Congenital long QT syndrome
•b.History or presence of significant ventricular or atrial tachyarrhythmia
•c.Clinically significant resting bradycardia (<50 beats per minute)
•d.QTc >500msec on screening ECG for both genders
•e.Right bundle branch block plus left anterior hemiblock, bifascicular block
•6.Other cardiac contraindications for intensive chemotherapy (L-VEF <50%)
•7.Uncontrolled, life-threatening infections
•8.Severe non controlled pulmonary or cardiac disease
•9.Severe hepatic or renal dysfunction
•10.HIV and/or active hepatitis C infection
•11.Active multiple sclerosis (patients with inactive MS can be included)
•12.Pregnant or breast-feeding patients
•13.Allergy to trial medication or excipients in study medication
•14.Substance abuse; medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results
•15.Use of other investigational drugs at the time of enrolment or within 30 days before study entry

发起方