Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
The proposed trial will address two clinically important questions for younger patients with
newly diagnosed acute myeloid leukemia (AML): the optimal dose of daunorubicin in induction
therapy and the necessity of a second induction cycle in patients with a good response after
the first induction. The primary endpoint is the rate of good responders. Secondary outcomes
will be relapse-free survival, overall survival and minimal residual disease kinetics.
Patients will be recruited in about 40 treatment centers of the Study Alliance Leukemia study
group over a period of 40 months. The results will be of great clinical relevance: First, the
study could facilitate the establishment or confirmation of the optimal daunorubicin dose.
Phase:
Phase 3
Details
Lead Sponsor:
Technische Universität Dresden
Collaborators:
Masaryk University Universitäts KrebsCentrum des Universitätsklinikums und der Medizinischen Fakultät an der TU Dresden Universitätsklinikum Dresden, Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC)