Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML

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.

Timeline

Start

2014-04-16

Primary completion

2022-04-25

Completion

2022-04-25

Publications

• Dendorfer SM, Schmidt-Brucken K, Kramer M, Steffen B, Schliemann C, Mikesch JH, Alakel N, Herbst R, Hanel M, Hanoun M, Kaufmann M, Weinbergerova B, Schafer-Eckart K, Sauer T, Neubauer A, Burchert A, Baldus CD, Mertova J, Jost E, Niemann D, Novak J, Krause SW, Scholl S, Hochhaus A, Held G, Szotkowski T, Rank A, Schmid C, Fransecky L, Kayser S, Schaich M, Fiebig F, Haake A, Schetelig J, Middeke JM, Stolzel F, Platzbecker U, Thiede C, Muller-Tidow C, Berdel WE, Ehninger G, Mayer J, Serve H, Bornhauser M, Rollig C. Randomized Comparison of Cardiotoxicity With 60 Versus 90 mg Daunorubicin in AML Induction Therapy. Am J Hematol. 2026 Mar;101(3):512-520. doi: 10.1002/ajh.70160. Epub 2026 Jan 5.

Drugs

Indications