newly diagnosed high-risk acute promyelocytic leukemia (APL) MedDRA version: 21.0 Level: PT Classification code 10001019 Term: Acute promyelocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Trisenox (R)
Product Name: Arsenic trioxide (ATO)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Arsenic trioxid
CAS Number: 1327-53-3
Current Sponsor code
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The primary endpoint of the study is event-free survival. This is a time to event endpoint. This cumulative endpoint includes the following events: no achievement of hematological complete remission after induction therapy; no achievement of molecular remission after the last consolidation course (molecular resistance); relapse (hematological/molecular); death including early death (within 30 days after randomization) or development of secondary myelodysplasia or leukemia.;Secondary Objective: - complete remission (CR) , overall survival (OS) and cumulative incidence of relapse (CIR) rates - cumulative incidence of secondary myelodysplastic syndromes or acute myeloid leukaemia - early death during induction - quality of life - toxicity profile - kinetics of MRD - duration of in-patient treatment - health economics ;Main Objective: To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen) in newly diagnosed high-risk APL;Primary end point(s): The primary endpoint of the study is event-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - complete remission (CR), overall survival (OS) and cumulative incidence of relapse (CIR) rates - cumulative incidence of secondary myelodysplastic syndromes or acute myeloid leukaemia - early death during induction - quality of life - toxicity profile - kinetics of MRD - duration of in-patient treatment - health economics ;Timepoint(s) of evaluation of this end point: -whole study | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Contacts
Public Contactcoordinating investigator
Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I
Outcome results
None listed