Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML (DaunoDouble)
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ClinicalTrials.gov Identifier: NCT02140242 |
Recruitment Status : Unknown
Verified August 2017 by Technische Universität Dresden.
Recruitment status was: Recruiting
First Posted : May 16, 2014
Last Update Posted : August 11, 2017
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Condition or disease | Intervention/treatment | Phase |
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Leukemia, Myelocytic, Acute | Drug: study part 1 - dose daunorubicin Procedure: induction cycles | Phase 3 |
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].
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 16, 2014 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | August 2018 |

Arm | Intervention/treatment |
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Active Comparator: daunorubicin 60 mg/m2
study part 1 - dose daunorubicin standard dose daunorubicin in induction 1 (60 mg/m2) on days 3-5
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Drug: study part 1 - dose daunorubicin
standard induction dose of daunorubicin 60 mg/m2 on days 3-5 |
Active Comparator: Double induction
study part 2: induction cycles double induction (only patients with good response)
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Procedure: induction cycles
single induction cycle versus double induction cycles (only patients with good response after first induction) Allocation is randomized for cytogenetic risk. |
Experimental: Single induction
study part 2: induction cycles single induction (only patients with good response)
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Procedure: induction cycles
single induction cycle versus double induction cycles (only patients with good response after first induction) Allocation is randomized for cytogenetic risk. |
- response rate after first induction [ Time Frame: day 15 ]To investigate whether a higher dose of daunorubicin in induction chemotherapy leads to an increase in hematological good responders defined as having <5% myeloid blasts on day 15 after start of induction therapy.
- Rate complete remissions [ Time Frame: day 35 after final induction ]To investigate whether the rate of complete remissions (CR) after single induction is similar to that after double induction in patients with good response to induction I.
- rate cytogenetic and molecular complete remissions [ Time Frame: day 35 ]To investigate whether a higher dose of daunorubicin in induction chemotherapy will lead to an increase in cytogenetic and molecular complete remissions.
- event-free survival (EFS) [ Time Frame: 5 years ]To investigate whether a higher dose of daunorubicin will lead to improved event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS). To investigate whether EFS, RFS and OS are similar after single versus double induction in patients with good response to induction I.
- relapse-free survival (RFS) [ Time Frame: 5 years ]To investigate whether a higher dose of daunorubicin will lead to improved event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS). To investigate whether EFS, RFS and OS are similar after single versus double induction in patients with good response to induction I.
- overall survival (OS) [ Time Frame: 5 years ]To investigate whether a higher dose of daunorubicin will lead to improved event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS). To investigate whether EFS, RFS and OS are similar after single versus double induction in patients with good response to induction I.
- Correlation between Minimal Residual Disease (MRD) and EFS, RFS, OS [ Time Frame: day 35 ]To correlate the level of cytogenetic and molecular minimal residual disease after induction treatment with survival outcomes EFS, RFS and OS.
- Rate of induction deaths [ Time Frame: day 60 ]Rate of induction deaths (until day 60 or beginning of consolidation treatment - whichever occurs first)
- Incidence of serious infectious complications [ Time Frame: day 35 ]Incidence of serious infectious complications Grades 3-4 (Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
- Sonographic cardiac left ventricular ejection fraction [ Time Frame: day 35 ]Sonographic cardiac left ventricular ejection fraction
- Serum levels of pro-brain natriuretic peptide (por-BNP) and Troponin-T [ Time Frame: day 35 ]Serum levels of pro-BNP and Trop-T
- Incidence of CTCAE grade ≥3 cardiac complications [ Time Frame: day 35 ]Incidence of CTCAE grade ≥3 cardiac complications
- Rate of early deaths [ Time Frame: week 2 ]Rate of early deaths (2 weeks)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain ≥20% blasts of all nucleated cells or differential blood count must contain ≥20% blasts. In acute erythroid leukemia, ≥20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
- Age 18- inkl.65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Total bilirubin ≤ 1.5 times the upper limit of normal
- alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times upper limit of normal
- Creatinine ≤ 1.5 times upper limit of normalExclusion Criteria:
- Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by transthoracic two-dimensional echocardiography ("M Mode") or multiple gated acquisition scan (MUGA scan)
- Signed informed consent
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Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
- Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum follicle stimulating hormone (FSH) > 40 U/ml)
- Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
- Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD).
- Sexual abstinence
- Vasectomy of the sexual partner
Exclusion criteria:
- Patients who are not eligible for standard chemotherapy as assessed by the treating physician
- Central nervous system manifestation of AML
- Cardiac disease: i.e. heart failure New York Heart Association (NYHA) III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Patients undergoing renal dialysis
- Chronic pulmonary disease with clinical relevant hypoxia
- Known HIV or Hepatitis infection
- Uncontrolled active infection
- Medical conditions other than AML with an estimated life expectancy below 6 months
- Previous treatment of AML except hydroxyurea up to 5 days
- Relapsed or primary refractory AML
- Acute promyelocytic leukemia
- Previous anthracycline-containing chemotherapy
- Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment
- Incapability of understanding purpose and possible consequences of the trial
- Pregnant or breastfeeding women
- Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140242
Contact: Frank Staps | +049 - 0351 458 5198 | frank.staps@uniklinikum-dresden.de | |
Contact: Annett Haake | +049 - 0351 458 3965 | annett.haake@uniklinikum-dresden.de |
Czechia | |
Interní klinika LF Masarykovy univerzity a Fakultní nemocnice Brno | Recruiting |
Brno, Czechia | |
Contact: Jirí Mayer, MD | |
Faculty Hospital Hradec Králové, II. Clinic of international medicine | Recruiting |
Hradec Králové, Czechia | |
Contact: Pavel Zák, doc. MUDr. | |
Fakultní nemocnice Olomouc | Recruiting |
Olomouc, Czechia | |
Contact: Tomas Szotkowski, Doc. Dr. | |
Fakultní nemocnice Královské Vinohrady | Recruiting |
Praha, Czechia | |
Contact: Jan Novák, MD | |
Ústav hematologie a krevní transfuze (ÚHKT) | Recruiting |
Praha, Czechia | |
Contact: Jolana Mertová, MUDr. | |
Germany | |
Uniklinik RWTH Aachen | Recruiting |
Aachen, Germany, 52074 | |
Contact: Edgar Jost, MD | |
Klinikum Altenburger Land GmbH | Recruiting |
Altenburg, Germany | |
Contact: Armin Schulz-Abelius, MD | |
Klinikum Augsburg | Enrolling by invitation |
Augsburg, Germany | |
Sozialstiftung Bamberg Klinikum am Bruderwald | Recruiting |
Bamberg, Germany | |
Contact: Martina Teichmann, MD | |
Charite Campus Benjamin Franklin | Recruiting |
Berlin, Germany | |
Contact: Claudia Baldus, Prof. | |
Klinikum Bielefeld | Recruiting |
Bielefeld, Germany | |
Contact: Martin Görner, MD | |
Augusta Kliniken Bochum Hattingen | Recruiting |
Bochum, Germany, 44791 | |
Contact: Dirk Behringer, Prof. | |
Ev. Diakonie-Krankenhaus gGmbH Bremen | Recruiting |
Bremen, Germany | |
Contact: Johannes Kullmer, MD | |
Klinikum Chemnitz GmbH | Recruiting |
Chemnitz, Germany | |
Contact: Mathias Hänel, MD | |
PD Dr. Christoph Röllig | Recruiting |
Dresden, Germany | |
Principal Investigator: Christoph Röllig, MD | |
Krankenhaus Düren gem. GmbH | Recruiting |
Düren, Germany | |
Contact: Michael Flaßhove, MD | |
Marienhospital Düsseldorf GmbH | Recruiting |
Düsseldorf, Germany | |
Contact: Aristoteles Giagounidis, MD | |
Universitätsklinikum Erlangen | Recruiting |
Erlangen, Germany | |
Contact: Stefan Krause, Prof. | |
Universitätsklinikum Essen | Recruiting |
Essen, Germany | |
Contact: Richard Noppeney, MD | |
Johann Wolfgang Goethe-Universität Frankfurt am Main | Recruiting |
Frankfurt am Main, Germany | |
Contact: Björn Steffen, MD | |
Universitätsklinikum Halle (Saale) | Recruiting |
Halle, Germany | |
Contact: Maxi Wass, MD | |
Asklepios Klinik St. Georg | Terminated |
Hamburg, Germany | |
St. Marien-Hospital Hamm | Recruiting |
Hamm, Germany | |
Contact: Heinz Albert Dürk, MD | |
Universitätsklinikum Heidelberg | Recruiting |
Heidelberg, Germany | |
Contact: Alwin Krämer, Prof. | |
St. Bernward Krankenhaus Hildesheim | Recruiting |
Hildesheim, Germany | |
Contact: Ulrich Kaiser, Prof. | |
Universitätsklinikum Jena | Recruiting |
Jena, Germany, 07740 | |
Contact: Sebastian Scholl, MD | |
Westpfalz-Klinikum GmbH | Recruiting |
Kaiserslautern, Germany | |
Contact: Stefan Mahlmann, MD | |
Städtisches Krankenhaus Kiel | Recruiting |
Kiel, Germany | |
Contact: Sebastian Buske, MD | |
Gemeinschaftsklinikum Mittelrhein GmbH | Recruiting |
Koblenz, Germany | |
Contact: Dirk Niemann, MD | |
Universitätsklinikum Gießen und Marburg | Recruiting |
Marburg, Germany | |
Contact: Andreas Neubauer, Prof. | |
Universitätsklinikum Münster | Recruiting |
Münster, Germany | |
Contact: Christoph Schliemann, MD | |
Klinikum Nürnberg-Nord | Recruiting |
Nürnberg, Germany | |
Contact: Kerstin Schäfer-Eckart, MD | |
Agaplesion Diakoniekrankenhaus Rotenburg | Recruiting |
Rotenburg, Germany | |
Contact: Frank Heits, MD | |
Diakonie-Klinikum Schwäbisch Hall gGmbH | Recruiting |
Schwäbisch Hall, Germany | |
Contact: Thomas Geer, MD | |
Klinikum Sindelfingen-Böblingen | Recruiting |
Sindelfingen, Germany | |
Contact: Markus Ritter, MD | |
Robert-Bosch-Krankenhaus | Recruiting |
Stuttgart, Germany | |
Contact: Martin Kaufmann, MD | |
Rems-Murr-Klinikum Winnenden | Recruiting |
Winnenden, Germany | |
Contact: Stefani Parmentier, MD |
Principal Investigator: | Christoph Röllig, PD Dr. med. | Universitätsklinikum Dresden Carl Gustav Carus |
Additional Information:
Responsible Party: | Technische Universität Dresden |
ClinicalTrials.gov Identifier: | NCT02140242 History of Changes |
Other Study ID Numbers: |
TUD-2DAUNO-058 |
First Posted: | May 16, 2014 Key Record Dates |
Last Update Posted: | August 11, 2017 |
Last Verified: | August 2017 |
AML leukemia induction treatment daunorubicin 7+3 |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Daunorubicin |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |