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 - APOLLO

FUNDACION PETHEMA0 个研究点目标入组 280 人开始时间: 2018年3月2日最近更新: 2018年6月18日

适应症

试验速览

暂无简介。

•- Informed consent
•- women or man with a newly diagnosed APL by cytomorphology, confirmed by molecular analysis
•- Age =18 and = 65 years
•- ECOG performance status 0-3
•- 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:
•o Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
•o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
•o Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
•o Sexual abstinence
•o Vasectomy of the sexual partner
•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 280
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- patients who are not eligible for chemotherapy as per discretion of the treating physician
•- APL secondary to previous radio- or chemotherapy for non-APL disease
•- other active malignancy at time of study entry (exception: Basal-Cell Carcinoma)
•- lack of diagnostic confirmation of APL at genetic level
•- Significant arrhythmias, ECG abnormalities
•- 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
•- HIV and/or active 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

发起方

FUNDACION PETHEMA