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Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML) (AMLCG 2008)

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ClinicalTrials.gov Identifier: NCT01382147
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Kompetenznetz Leukämien
Information provided by (Responsible Party):
Prof. Dr. Wolfgang Hiddemann, Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : July 5, 2017


Arm Intervention/treatment
Experimental: S-HAM
S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Chemotherapy

Active Comparator: TAD-HAM (younger) or HAM-HAM (elderly)
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
Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Chemotherapy




Primary Outcome Measures :
  1. 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]. [ Time Frame: 8 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01382147


Locations
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Germany
Vinzenz-Pallotti-Hospital, Innere Abteilung
Bergisch-Gladbach, Germany, 51429
St. Hedwig Krankenhaus, Abteilung Innere Medizin
Berlin, Germany, 10115
Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie
Berlin, Germany, 12351
HELIOS Klinikum Berlin-Buch, Klinik für Haematologie, Onkologie und Tumorimmunologie
Berlin, Germany, 13125
Vivantes Klinikum Spandau, Klinik fuer Innere Medizin, Haematologie, Onkologie, Gastroenterologie und Palliativmedizin
Berlin, Germany, 13585
Evangelisches Waldkrankenhaus Spandau
Berlin, Germany, 13589
Evangelisches Krankenhaus Bielefeld gGmbH, Klinik fuer Innere Medizin, Haematologie, Onkologie und Palliativmedizin
Bielefeld, Germany, 44791
Augusta-Krankenanstalt, Klinik fuer Haematologie, Onkologie und Palliativmedizin
Bochum, Germany, 44791
Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus, Innere Medizin I
Bonn, Germany, 53113
Knappschaftskrankenhaus Bottrop, Klinik fuer Innere Medizin
Bottrop, Germany, 46242
St.-Johannes Hospital Dortmund, Klinik fuer Innere Medizin II
Dortmund, Germany, 44137
St.-Antonius-Hospital Eschweiler, Klinik fuer Haematologie und internistische Onkologie
Eschweiler, Germany, 52249
Klinikum Frankfurt / Oder GmbH, Medizinische Klinik I
Frankfurt / Oder, Germany, 15236
St.-Josef-Hospital Gelsenkirchen-Horst, Klinik für Medizinische und Radiologische Onkologie, Hämatologie und Palliativmedizin
Gelsenkirchen, Germany, 45899
Städtisches Klinikum Gütersloh, Medizinische Klinik II
Gütersloh, Germany, 33332
Kath. Krankenhaus Hagen GmbH, Klinik fuer Haematologie und Onkologie
Hagen, Germany, 58095
Klinikum Herford, Medizinische Klinik II
Herford, Germany, 32049
Universitaetsklinikum Köln, Klinik I fuer Innere Medizin
Köln, Germany, 50924
Klinikum Leverkusen gGmbH, Medizinische Klinik III
Leverkusen, Germany, 51375
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Medizinische Klinik A
Ludwigshafen, Germany, 67063
Universitätsklinikum Schleswig-Holstein, Medizinische Klinik I, Haematologie / Onkologie
Luebbeck, Germany, 23538
Medizinische Fakultaet Mannheim der Universitaet Heidelberg, III. Medizinische Klinik Haematologie und Internistische Onkologie
Mannheim, Germany, 68167
Carl-von-Basedow-Klinikum Saalekreis GmbH, Medizinische Klinik II
Merseburg, Germany, 06217
Krankenhaus Maria Hilf GmbH, Krankenhaus St. Franziskus, Medizinische Klinik I
Moenchengladbach, Germany, 41063
Klinikum der Universitaet Muenchen Medizinische Klinik und Polikklinik III
Muenchen, Germany, 81377
Staedtisches Klinikum Harlaching, Klinik für Onkologie und Haematologie
Muenchen, Germany, 81545
Klinikum Osnabrück, Klinik fuer Haematologie / Onkologie
Osnabrück, Germany, 49076
Brüderkrankenhaus St. Josef Paderborn, Klinik fuer Haematologie / Onkologie
Paderborn, Germany, 33098
Krankenhaus Barmherzige Brüder , Klinik fuer internistische Onkologie und Haematologie
Regensburg, Germany, 93049
St.-Marien-Krankenhaus Siegen gem. GmbH, Medizinische Klinik III
Siegen, Germany, 57072
Stiftung Deutsche Klinik für Diagnostik GmbH, Zentrum fuer Knochenmark- und Stammzelltransplantation
Wiesbaden, Germany, 65191
Klinikum Idar-Oberstein GmbH, Innere Medizin I, Abteilung Haematologie / Onkologie
Îdar-Oberstein, Germany, 55743
Sponsors and Collaborators
Prof. Dr. Wolfgang Hiddemann
Kompetenznetz Leukämien
Investigators
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Principal Investigator: Wolfgang Hiddemann, Prof. Dr. Hospital of the University of Munich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Wolfgang Hiddemann, Director of the Department of Medicine III, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01382147     History of Changes
Other Study ID Numbers: 2007-003103-12
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
Mitoxantrone
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs