This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy. Sample size: 144 patients Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial) Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient will last additional 2 years)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
in all treatment cycles: Cytarabine 20 mg/day, s.c., bid, days 1-7; (total dose 280 mg).
first treatment cycle Etoposide 50 mg/m²/day, continuously i.v., days 1-3; (total dose 150 mg/m2) treatment cycles 2 to 6 Etoposide 100 mg/day, p.o. or i.v. (over 1 hour), days 1-3; (total dose 300 mg).
in all treatment cycles: ATRA 45 mg/m²/day p.o., days 8-10, ATRA 15 mg/m²/day p.o., days 11-28, with or shortly after meals distributed on 3 doses per day.
Ubbo-Emmius Klinik Aurich
Aurich, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
University Hospital of Bonn
Bonn, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Germany
Klinikum Bremen-Mitte gGmbH
Bremen, Germany
Kliniken Essen Süd, Evangelischs Krankenhaus
overall survival
Time frame: 2 years and 8 months
Rate of Complete remission
Time frame: 8 months
cumulative incidence of relapse
Time frame: 2 years and 8 months
cumulative incidence of death in complete remission
Time frame: 2 years and 8 months
event-free survival
Time frame: 2 years and 8 months
Rate of early deaths (ED)/hypoplastic deaths (HD)
Time frame: 8 months
Type, frequency, severity, timing and relatedness of adverse events (AEs) and laboratory abnormalities observed during different treatment cycles
adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 4.0
Time frame: 8 months
Incidence of infection after each treatment cycle
Time frame: 8 months
Duration of neutropenia after each treatment cycle
Time frame: 8 months
Duration of thrombocytopenia after each treatment cycle
Time frame: 8 months
Duration of hospitalization after each treatment cycle
Time frame: 8 months
Quality of life
assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al.33
Time frame: 2 years and 8 months
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Essen, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
Medizinische Universitätsklinik
Freiburg im Breisgau, Germany
Medizinisches Versorgungszentrum Osthessen GmbH
Fulda, Germany
Universitätsklinikum Gießen
Giessen, Germany
...and 23 more locations