Acute Myeloid Leukemia Clinical Trial
— AMLCG 2008Official title:
A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (Sequential High Dose Cytosine Arabinoside and Mitoxantrone) Versus Standard Double Induction for Initial Chemotherapy of Adult Patients With Acute Myeloid Leukemia
| Verified date | December 2017 |
| Source | Ludwig-Maximilians - University of Munich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 396 |
| Est. completion date | July 5, 2017 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Vinzenz-Pallotti-Hospital, Innere Abteilung | Bergisch-Gladbach | |
| Germany | Evangelisches Waldkrankenhaus Spandau | Berlin | |
| Germany | HELIOS Klinikum Berlin-Buch, Klinik für Haematologie, Onkologie und Tumorimmunologie | Berlin | |
| Germany | St. Hedwig Krankenhaus, Abteilung Innere Medizin | Berlin | |
| Germany | Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie | Berlin | |
| Germany | Vivantes Klinikum Spandau, Klinik fuer Innere Medizin, Haematologie, Onkologie, Gastroenterologie und Palliativmedizin | Berlin | |
| Germany | Evangelisches Krankenhaus Bielefeld gGmbH, Klinik fuer Innere Medizin, Haematologie, Onkologie und Palliativmedizin | Bielefeld | |
| Germany | Augusta-Krankenanstalt, Klinik fuer Haematologie, Onkologie und Palliativmedizin | Bochum | |
| Germany | Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Innere Medizin I | Bonn | |
| Germany | Knappschaftskrankenhaus Bottrop, Klinik fuer Innere Medizin | Bottrop | |
| Germany | St.-Johannes Hospital Dortmund, Klinik fuer Innere Medizin II | Dortmund | |
| Germany | St.-Antonius-Hospital Eschweiler, Klinik fuer Haematologie und internistische Onkologie | Eschweiler | |
| Germany | Klinikum Frankfurt / Oder GmbH, Medizinische Klinik I | Frankfurt / Oder | |
| Germany | St.-Josef-Hospital Gelsenkirchen-Horst, Klinik für Medizinische und Radiologische Onkologie, Hämatologie und Palliativmedizin | Gelsenkirchen | |
| Germany | Städtisches Klinikum Gütersloh, Medizinische Klinik II | Gütersloh | |
| Germany | Kath. Krankenhaus Hagen GmbH, Klinik fuer Haematologie und Onkologie | Hagen | |
| Germany | Klinikum Herford, Medizinische Klinik II | Herford | |
| Germany | Klinikum Idar-Oberstein GmbH, Innere Medizin I, Abteilung Haematologie / Onkologie | Îdar-Oberstein | |
| Germany | Universitaetsklinikum Köln, Klinik I fuer Innere Medizin | Köln | |
| Germany | Klinikum Leverkusen gGmbH, Medizinische Klinik III | Leverkusen | |
| Germany | Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Medizinische Klinik A | Ludwigshafen | |
| 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 | Carl-von-Basedow-Klinikum Saalekreis GmbH, Medizinische Klinik II | Merseburg | |
| Germany | Krankenhaus Maria Hilf GmbH, Krankenhaus St. Franziskus, Medizinische Klinik I | Moenchengladbach | |
| Germany | Klinikum der Universitaet Muenchen Medizinische Klinik und Polikklinik III | Muenchen | |
| Germany | Staedtisches Klinikum Harlaching, Klinik für Onkologie und Haematologie | Muenchen | |
| Germany | Klinikum Osnabrück, Klinik fuer Haematologie / Onkologie | Osnabrück | |
| Germany | Brüderkrankenhaus St. Josef Paderborn, Klinik fuer Haematologie / Onkologie | Paderborn | |
| Germany | Krankenhaus Barmherzige Brüder , Klinik fuer internistische Onkologie und Haematologie | Regensburg | |
| Germany | St.-Marien-Krankenhaus Siegen gem. GmbH, Medizinische Klinik III | Siegen | |
| Germany | Stiftung Deutsche Klinik für Diagnostik GmbH, Zentrum fuer Knochenmark- und Stammzelltransplantation | Wiesbaden |
| Lead Sponsor | Collaborator |
|---|---|
| Prof. Dr. Wolfgang Hiddemann | Kompetenznetz Leukämien |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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|---|---|---|---|
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