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Brief Title: Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML
Official Title: 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
Study ID: NCT02140242
Brief 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.
Detailed Description: In the first part of the trial, patients will be randomly assigned to receive either 90 mg/m2 or 60 mg/m2 daunorubicin in the first induction cycle in addition to standard dosed cytarabine. Assuming a superiority of 90 mg/m2, 436 patients will be recruited. In the second part of the trial, good responders will be randomized to receive either a second or no further induction cycle. Assuming a non-inferiority of the single induction regarding the rate of complete remissions, a number of 360 patients will be included in the second part. Furthermore, in case of a non-inferiority of single versus double induction in good responders, about half of all younger AML patients could be spared a second induction cycle, leading to a reduction in treatment-related mortality, fewer days spent in hospital and improved quality of life. As a result of the preplanned interim analysis of part I, the sponsor decided to suspend randomization in trial part I and to offer all patients the standard dose of 60 mg/m2 daunorubicin in both induction cycles (part I and II of the trial). Because of this an Amendment was sent to and approved by regulatories and ethics comitee. The inclusion age was raised to 65 years based on the current German treatment guidelines in which patients up to the age of 65 are considered eligible for intensive induction chemotherapy with DA60 \[Onkopedia-Leitlinie 2017\].
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Interní klinika LF Masarykovy univerzity a Fakultní nemocnice Brno, Brno, , Czechia
Faculty Hospital Hradec Králové, II. Clinic of international medicine, Hradec Králové, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Fakultní nemocnice Královské Vinohrady, Praha, , Czechia
Ústav hematologie a krevní transfuze (ÚHKT), Praha, , Czechia
Uniklinik RWTH Aachen, Aachen, , Germany
Klinikum Altenburger Land GmbH, Altenburg, , Germany
Klinikum Augsburg, Augsburg, , Germany
Sozialstiftung Bamberg Klinikum am Bruderwald, Bamberg, , Germany
Charite Campus Benjamin Franklin, Berlin, , Germany
Helios Klinikum Berlin-Buch, Berlin, , Germany
Klinikum Bielefeld, Bielefeld, , Germany
Augusta Kliniken Bochum Hattingen, Bochum, , Germany
Ev. Diakonie-Krankenhaus gGmbH Bremen, Bremen, , Germany
Klinikum Chemnitz GmbH, Chemnitz, , Germany
Carl.Thiem-Klinikum Cottbus gGmbH, Cottbus, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Krankenhaus Düren gem. GmbH, Düren, , Germany
Marienhospital Düsseldorf GmbH, Düsseldorf, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Universitätsklinikum Essen, Essen, , Germany
Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main, , Germany
Universitätsklinikum Halle (Saale), Halle, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
St. Marien-Hospital Hamm, Hamm, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
St. Bernward Krankenhaus Hildesheim, Hildesheim, , Germany
Universitätsklinikum Jena, Jena, , Germany
Westpfalz-Klinikum GmbH, Kaiserslautern, , Germany
Städtisches Krankenhaus Kiel, Kiel, , Germany
Gemeinschaftsklinikum Mittelrhein GmbH, Koblenz, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Universitätsklinikum Gießen und Marburg, Marburg, , Germany
Universitätsklinikum Münster, Münster, , Germany
Klinikum Nürnberg-Nord, Nürnberg, , Germany
Diakonie-Klinikum Schwäbisch Hall gGmbH, Schwäbisch Hall, , Germany
Robert-Bosch-Krankenhaus, Stuttgart, , Germany
Rems-Murr-Klinikum Winnenden, Winnenden, , Germany
Name: Christoph Röllig, Prof. Dr.
Affiliation: Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I
Role: PRINCIPAL_INVESTIGATOR