At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Comparison Between Two Dose Levels of Daunorubicin and Between One Versus Two Cycles of Induction Therapy for Adult Patients With Acute Myeloid Leukemia ≤65 Years
In Brief
A Phase 3 clinical trial evaluating study part 1 - dose daunorubicin and induction cycles for Leukemia, Myelocytic, Acute. Completed, enrolled 721 participants across 38 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
standard induction dose of daunorubicin 60 mg/m2 on days 3-5
single induction cycle versus double induction cycles (only patients with good response after first induction) Allocation is randomized for cytogenetic risk.