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Spots Global Cancer Trial Database for Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML

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Trial Identification

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

Study Description

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 \[Onkopedia-Leitlinie 2017\].

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Christoph Röllig, Prof. Dr.

Affiliation: Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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