Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
- Registration Number
- NCT01382147
- Lead Sponsor
- Prof. Dr. Wolfgang Hiddemann
- Brief Summary
Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 396
- Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to the WHO classification including patients with secondary AML and AML after preceding hematologic disorders
- Age 18 years or older
- Informed consent. Before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.
- Acute promyelocytic leukemia (APL)
- Previous or concurrent malignancies other than AML
- Previous treatment with colony-stimulating factors, interleukins or interferons
- Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®)
- Antibody-based or cell-based immunotherapies
- Respiratory insufficiency with pO2 <60 mmHg
- Heart failure NYHA III° or IV°
- Elevated creatinine >2.0 mg/dl
- Elevated bilirubin >2.0 mg/dl
- Pregnancy or lactation
- Females without adequate contraception
- Known HIV and/or hepatitis C infection
- Severe neurologic or psychiatric disease
- Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study
- Concerns for subject's compliance with the protocol procedures
- Lack of willingness to record and circulate personal disease-related informations defined in the study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAD-HAM (younger) or HAM-HAM (elderly) Ara-C, Mitoxantrone, Daunorubicin, Thioguanin is TAD-9 - HAM for younger patients (with 2 mandatory induction cycles) and HAM (- HAM) for the elderly patients with the second HAM cycle only applied in the case of inadequate blast clearance (\> 5%) in the day 16 bone marrow aspirate S-HAM Ara-C, Mitoxantrone, Daunorubicin, Thioguanin S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
- Primary Outcome Measures
Name Time Method Overall response rate, aiming at a 15% increase in the CR/PR rate by S-HAM induction versus conventional double induction [TAD - HAM for younger patients, HAM (- HAM) for elderly patients]. 8 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
HELIOS Klinikum Berlin-Buch, Klinik für Haematologie, Onkologie und Tumorimmunologie
🇩🇪Berlin, Germany
Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie
🇩🇪Berlin, Germany
St.-Josef-Hospital Gelsenkirchen-Horst, Klinik für Medizinische und Radiologische Onkologie, Hämatologie und Palliativmedizin
🇩🇪Gelsenkirchen, Germany
Klinikum Herford, Medizinische Klinik II
🇩🇪Herford, Germany
Universitaetsklinikum Köln, Klinik I fuer Innere Medizin
🇩🇪Köln, Germany
Universitätsklinikum Schleswig-Holstein, Medizinische Klinik I, Haematologie / Onkologie
🇩🇪Luebbeck, Germany
Medizinische Fakultaet Mannheim der Universitaet Heidelberg, III. Medizinische Klinik Haematologie und Internistische Onkologie
🇩🇪Mannheim, Germany
Klinikum Osnabrück, Klinik fuer Haematologie / Onkologie
🇩🇪Osnabrück, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Medizinische Klinik A
🇩🇪Ludwigshafen, Germany
Evangelisches Krankenhaus Bielefeld gGmbH, Klinik fuer Innere Medizin, Haematologie, Onkologie und Palliativmedizin
🇩🇪Bielefeld, Germany
St.-Antonius-Hospital Eschweiler, Klinik fuer Haematologie und internistische Onkologie
🇩🇪Eschweiler, Germany
Stiftung Deutsche Klinik für Diagnostik GmbH, Zentrum fuer Knochenmark- und Stammzelltransplantation
🇩🇪Wiesbaden, Germany
St. Hedwig Krankenhaus, Abteilung Innere Medizin
🇩🇪Berlin, Germany
Klinikum Leverkusen gGmbH, Medizinische Klinik III
🇩🇪Leverkusen, Germany
Vinzenz-Pallotti-Hospital, Innere Abteilung
🇩🇪Bergisch-Gladbach, Germany
Augusta-Krankenanstalt, Klinik fuer Haematologie, Onkologie und Palliativmedizin
🇩🇪Bochum, Germany
St.-Johannes Hospital Dortmund, Klinik fuer Innere Medizin II
🇩🇪Dortmund, Germany
Evangelisches Waldkrankenhaus Spandau
🇩🇪Berlin, Germany
Knappschaftskrankenhaus Bottrop, Klinik fuer Innere Medizin
🇩🇪Bottrop, Germany
Carl-von-Basedow-Klinikum Saalekreis GmbH, Medizinische Klinik II
🇩🇪Merseburg, Germany
Klinikum der Universitaet Muenchen Medizinische Klinik und Polikklinik III
🇩🇪Muenchen, Germany
Krankenhaus Barmherzige Brüder , Klinik fuer internistische Onkologie und Haematologie
🇩🇪Regensburg, Germany
Vivantes Klinikum Spandau, Klinik fuer Innere Medizin, Haematologie, Onkologie, Gastroenterologie und Palliativmedizin
🇩🇪Berlin, Germany
Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Innere Medizin I
🇩🇪Bonn, Germany
Klinikum Frankfurt / Oder GmbH, Medizinische Klinik I
🇩🇪Frankfurt / Oder, Germany
Städtisches Klinikum Gütersloh, Medizinische Klinik II
🇩🇪Gütersloh, Germany
Kath. Krankenhaus Hagen GmbH, Klinik fuer Haematologie und Onkologie
🇩🇪Hagen, Germany
St.-Marien-Krankenhaus Siegen gem. GmbH, Medizinische Klinik III
🇩🇪Siegen, Germany
Klinikum Idar-Oberstein GmbH, Innere Medizin I, Abteilung Haematologie / Onkologie
🇩🇪Îdar-Oberstein, Germany
Krankenhaus Maria Hilf GmbH, Krankenhaus St. Franziskus, Medizinische Klinik I
🇩🇪Moenchengladbach, Germany
Staedtisches Klinikum Harlaching, Klinik für Onkologie und Haematologie
🇩🇪Muenchen, Germany
Brüderkrankenhaus St. Josef Paderborn, Klinik fuer Haematologie / Onkologie
🇩🇪Paderborn, Germany