Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML)
NCT ID: NCT01382147
Last Updated: 2017-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
396 participants
INTERVENTIONAL
2009-07-01
2017-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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S-HAM
S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Chemotherapy
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
Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Chemotherapy
Interventions
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Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Kompetenznetz Leukämien
UNKNOWN
Prof. Dr. Wolfgang Hiddemann
OTHER
Responsible Party
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Prof. Dr. Wolfgang Hiddemann
Director of the Department of Medicine III
Principal Investigators
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Wolfgang Hiddemann, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital of the University of Munich
Locations
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Vinzenz-Pallotti-Hospital, Innere Abteilung
Bergisch Gladbach, , Germany
St. Hedwig Krankenhaus, Abteilung Innere Medizin
Berlin, , Germany
Vivantes Klinikum Neukoelln, Innere Medizin - Haematologie und Onkologie
Berlin, , Germany
HELIOS Klinikum Berlin-Buch, Klinik für Haematologie, Onkologie und Tumorimmunologie
Berlin, , Germany
Vivantes Klinikum Spandau, Klinik fuer Innere Medizin, Haematologie, Onkologie, Gastroenterologie und Palliativmedizin
Berlin, , Germany
Evangelisches Waldkrankenhaus Spandau
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
Universitaetsklinikum Köln, Klinik I fuer Innere Medizin
Cologne, , 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
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
Mönchengladbach, , Germany
Klinikum der Universitaet Muenchen Medizinische Klinik und Polikklinik III
München, , Germany
Staedtisches Klinikum Harlaching, Klinik für Onkologie und Haematologie
München, , 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, , Germany
Countries
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References
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Archer KJ, Fu H, Mrozek K, Nicolet D, Mims AS, Uy GL, Stock W, Byrd JC, Hiddemann W, Braess J, Spiekermann K, Metzeler KH, Herold T, Eisfeld AK. Identifying long-term survivors and those at higher or lower risk of relapse among patients with cytogenetically normal acute myeloid leukemia using a high-dimensional mixture cure model. J Hematol Oncol. 2024 May 3;17(1):28. doi: 10.1186/s13045-024-01553-6.
Pastore F, Gittinger H, Raab S, Tschuri S, Ksienzyk B, Konstandin NP, Schneider S, Rothenberg-Thurley M, Horny HP, Werner M, Sauerland MC, Amler S, Gorlich D, Berdel WE, Wormann B, Braess J, Hiddemann W, Tischer J, Herold T, Metzeler KH, Spiekermann K. Acute megakaryoblastic leukaemia shows high frequency of chromosome 1q aberrations and dismal outcome. Br J Haematol. 2023 Sep;202(6):1165-1177. doi: 10.1111/bjh.18982. Epub 2023 Jul 16.
Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.
Konstandin NP, Pastore F, Herold T, Dufour A, Rothenberg-Thurley M, Hinrichsen T, Ksienzyk B, Tschuri S, Schneider S, Hoster E, Berdel WE, Woermann BJ, Sauerland MC, Braess J, Bohlander SK, Klein HG, Hiddemann W, Metzeler KH, Spiekermann K. Genetic heterogeneity of cytogenetically normal AML with mutations of CEBPA. Blood Adv. 2018 Oct 23;2(20):2724-2731. doi: 10.1182/bloodadvances.2018016840.
Hubmann M, Kohnke T, Hoster E, Schneider S, Dufour A, Zellmeier E, Fiegl M, Braess J, Bohlander SK, Subklewe M, Sauerland MC, Berdel WE, Buchner T, Wormann B, Hiddemann W, Spiekermann K. Molecular response assessment by quantitative real-time polymerase chain reaction after induction therapy in NPM1-mutated patients identifies those at high risk of relapse. Haematologica. 2014 Aug;99(8):1317-25. doi: 10.3324/haematol.2014.104133. Epub 2014 May 9.
Greif PA, Dufour A, Konstandin NP, Ksienzyk B, Zellmeier E, Tizazu B, Sturm J, Benthaus T, Herold T, Yaghmaie M, Dorge P, Hopfner KP, Hauser A, Graf A, Krebs S, Blum H, Kakadia PM, Schneider S, Hoster E, Schneider F, Stanulla M, Braess J, Sauerland MC, Berdel WE, Buchner T, Woermann BJ, Hiddemann W, Spiekermann K, Bohlander SK. GATA2 zinc finger 1 mutations associated with biallelic CEBPA mutations define a unique genetic entity of acute myeloid leukemia. Blood. 2012 Jul 12;120(2):395-403. doi: 10.1182/blood-2012-01-403220. Epub 2012 May 30.
Other Identifiers
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2007-003103-12
Identifier Type: -
Identifier Source: org_study_id