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| Sponsor: | III. Medizinische Klinik Mannheim |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025402 |
Purpose
RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether chemotherapy is more effective with or without interferon alfa and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous leukemia.
PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy, biological therapy, and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: filgrastim Biological: recombinant interferon alfa Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: hydroxyurea Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia (CML) Interferon-a Vs. Allogeneic Stem Cell Transplantation Vs. High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase |
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 1997 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to eligibility for transplantation (yes vs no).
All patients undergo cytoreduction comprising hydroxyurea (HU) IV daily.
Patients who are ineligible for or refuse transplantation are randomized to 1 of 2 treatment arms.
Patients who are eligible for transplantation with a related donor undergo allogeneic bone marrow transplantation. Patients may receive HU or IFN prior to transplantation. Patients may also receive oral high-dose busulfan daily for 4 days with or without cyclophosphamide or cyclophosphamide with total body irradiation.
Patients who are eligible for transplantation but do not have a related donor undergo peripheral blood stem cell (PBSC) harvest and are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 3 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within 5 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia in chronic phase
Patients negative for Philadelphia chromosome and BCR-ABL translocation must fulfill at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| Czech Republic | |
| Masaryk University Hospital | |
| Brno, Czech Republic, 62500 | |
| Germany | |
| Allgemeines Krankenhaus Altona | |
| Hamburg, Germany, 22763 | |
| Allgemeines Krankenhaus Hagen | |
| Hagen, Germany, D-58095 | |
| Asklepios Klinik Barmbek | |
| Hamburg, Germany, D-22291 | |
| Bundeswehr Krakenhaus | |
| Ulm, Germany, D-89070 | |
| Caritas - Krakenhaus Lebach | |
| Lebach, Germany, 66822 | |
| Caritasklinik St. Theresia | |
| Saarbrucken, Germany, D-66113 | |
| Charite - Campus Charite Mitte | |
| Berlin, Germany, D-10117 | |
| Charite - Campus Virchow Klinikum | |
| Berlin, Germany, D-13353 | |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | |
| Idar-Oberstein, Germany, D-55743 | |
| Deutsche Klinik fuer Diagnostik | |
| Wiesbaden, Germany, D-65191 | |
| Diakonie Klinikum Stuttgart | |
| Stuttgart, Germany, D-70176 | |
| Diakonissen - Krankenhaus | |
| Karlsruhe-Rueppur, Germany, 76199 | |
| DR Herbert - Nieper Krankenhaus Goslar | |
| Goslar, Germany, 38642 | |
| Europahochhaus | |
| Bochum, Germany, 44787 | |
| Evangelische Krankenhaus Hamm | |
| Hamm, Germany, D-59063 | |
| Evangelisches Krankenhaus Essen Werden | |
| Essen, Germany, D-45239 | |
| Franziskus Hospital | |
| Bietigheim, Germany, 74321 | |
| Gemeinschaftspraxis Brunoehler | |
| Karlsruhe, Germany, 76135 | |
| Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie | |
| Ansbach, Germany, 91522 | |
| Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie | |
| Giessen, Germany, 35392 | |
| Gemeinschaftspraxis | |
| Munich, Germany, 80331 | |
| Gemeinschaftspraxis | |
| Niddatel-IIbenstadt, Germany, 61194 | |
| Gemeinschaftspraxis | |
| Mannheim, Germany, D-68161 | |
| Gemeinschaftspraxis | |
| Nuernberg, Germany, D-90402 | |
| Haematologie Und Internistische Onkologie | |
| Hanau, Germany, 63450 | |
| Haematologisch Onkologische Praxis | |
| Aachen, Germany, D-52070 | |
| Haematologische / Onkologische Schwerpunktpraxis | |
| Krefeld, Germany, 47798 | |
| Haematologische Praxis | |
| Augsburg, Germany, 86150 | |
| Haematologische Praxis | |
| Stuttgart, Germany, D-70173 | |
| Haematologisch-Onkologische Praxis Altona | |
| Hamburg, Germany, D-22767 | |
| Haematologisch-Onkologische Schwerpunktpraxis | |
| Berlin, Germany, 13357 | |
| Hans - Susemihl - Krankenhaus | |
| Emden, Germany, 26721 | |
| Helios Kliniken Wuppertal University Hospital | |
| Wuppertal, Germany, D-42283 | |
| Helios Klinikum Berlin | |
| Berlin, Germany, 13125 | |
| Hematologische Onkologische Praxis | |
| Regensburg, Germany, 93047 | |
| Hematologische Praxis | |
| Oldenburg, Germany, 26121 | |
| Hermann - Holthusen Institute for Radiotherapy | |
| Hamburg, Germany, D-20099 | |
| II Medizinische Klinik - Klinikum Fuerth | |
| Fuerth, Germany, D-90766 | |
| II. Medizinische Klinik | |
| Aschaffenburg, Germany, RG 63739 | |
| III Medizinische Klinik Mannheim | |
| Mannheim, Germany, D-68305 | |
| Internistiche Praxis | |
| Erfurt, Germany, 99084 | |
| Jakobi Krankenhaus | |
| Rheine, Germany, 48431 | |
| Kinderklinik - Universitaetsklinikum Aachen | |
| Aachen, Germany, D-52074 | |
| Kinderklinik der Freier Universitaet Berlin | |
| Berlin, Germany, D-14059 | |
| Klinik fuer Onkologie - Katharinenhospital Stuttgart | |
| Stuttgart, Germany, D-70174 | |
| Klinik fuer Radioonkologie und Strahlentherapie | |
| Goeppingen, Germany, 73035 | |
| Kreiskrankenhaus | |
| Bad Hersfeld, Germany, 36251 | |
| Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster | |
| Muenster, Germany, D-48129 | |
| Klinik und Poliklinik fuer Urologie und Kinderurologie | |
| Giessen, Germany, D-35392 | |
| Kliniken St. Antonius | |
| Wuppertal 2, Germany, D-42283 | |
| Klinikum Augsburg | |
| Augsburg, Germany, DOH-86156 | |
| Klinikum Bremen-Mitte | |
| Bremen, Germany, D-28205 | |
| Klinikum Coburg | |
| Coburg, Germany, 96450 | |
| Klinikum der Friedrich-Schiller Universitaet Jena | |
| Jena, Germany, D-07740 | |
| Klinikum Der Hansestadt Stralsund - Klin. West | |
| Stralsund, Germany, D-18410 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, D-60590 | |
| Klinikum der Stadt Ludwigshafen am Rhein | |
| Ludwigshafen am Rhein, Germany, D-67063 | |
| Klinikum Der Stadt Villingen - Schwenningen | |
| Villingen-Schwenningen, Germany, D-78054 | |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | |
| Munich, Germany, D-81377 | |
| Klinikum der Universitaet Regensburg | |
| Regensburg, Germany, D-93053 | |
| Klinikum Erfurt | |
| Erfurt, Germany, 99089 | |
| Klinikum Garmisch - Partenkirchen GmbH | |
| Garmisch-Partenkirchen, Germany, D-82467 | |
| Klinikum Herford | |
| Herford, Germany, D-32049 | |
| Klinikum Kassel | |
| Kassel, Germany, D-34125 | |
| Klinikum Kempten Oberallgaeu | |
| Kempten, Germany, D-87439 | |
| Klinikum Krefeld GmbH | |
| Krefeld, Germany, D-47805 | |
| Klinikum Lippe - Lemgo | |
| Lemgo, Germany, D-32657 | |
| Klinikum Minden | |
| Minden, Germany, D-32423 | |
| Klinikum Nuernberg - Klinikum Nord | |
| Nuernberg, Germany, D-90419 | |
| Klinikum Nuernberg - Klinikum Sued | |
| Nuernberg, Germany, D-90471 | |
| Klinikum Oldenburg | |
| Oldenburg, Germany, D-26133 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Klinikum Remscheid GmbH | |
| Remscheid, Germany, D-42859 | |
| Klinikum St. Marien | |
| Amberg, Germany, D-92224 | |
| Krankenanstalt Mutterhaus der Borromaerinnen | |
| Trier, Germany, D-54219 | |
| Krankenhaus Barmherzige Brueder Regensburg | |
| Regensburg, Germany, D-93049 | |
| Krankenhaus Bietigheim | |
| Bietigheim, Germany, 74321 | |
| Krankenhaus Dueren | |
| Dueren, Germany, 52351 | |
| Krankenhaus Hohe Warte Mediziniche Klinik | |
| Bayreuth, Germany, 95445 | |
| Krankenhaus Maria Hilf GmbH | |
| Moenchengladbach, Germany, DOH-41063 | |
| Krankenhaus Muenchen Neuperlach | |
| Munich, Germany, D-81737 | |
| Krankenhaus Muenchen Schwabing | |
| Munich, Germany, 80804 | |
| Krankenhaus Neukoelln | |
| Berlin, Germany, D-12313 | |
| Krankenhaus Siloah - Medizinische Klinik II | |
| Hannover, Germany, D-30449 | |
| Krankenhaus St. Michael | |
| Voeklingen, Germany, 66333 | |
| Kreiskrankenhaus Boeblingen | |
| Boeblingen, Germany, 71032 | |
| Kreiskrankenhaus Fuessen | |
| Fuessen, Germany, 87629 | |
| Kreiskrankenhaus Mellrichstadt | |
| Mellrichstad, Germany, DT-97638 | |
| Kreiskrankenhaus Radebeul | |
| Radebeul, Germany, D-01445 | |
| Kreiskrankenhaus Siegen | |
| Siegen, Germany, D-57076 | |
| Kreiskrankenhaus | |
| Waldroel, Germany, 51545 | |
| Kreiskrankenhaus | |
| Aalen, Germany, 73430 | |
| Klinik Konstanz | |
| Konstanz, Germany, 78461 | |
| Luisenkrankenhaus | |
| Lindenfels, Germany, 64678 | |
| Malteser Krankenhaus | |
| Flensburg, Germany, D-24939 | |
| Marienhospital Bottrop gGmbH | |
| Bottrop, Germany, D-46236 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Medizinische Kl. Klinikum Innenstadt Universitaet Muenchen | |
| Munich, Germany, D-80336 | |
| Medizinische Klinik Am Lukas - Krankenhaus | |
| Buende, Germany, 32257 | |
| Medizinische Klinik I | |
| Dresden, Germany, D-01307 | |
| Medizinische Klinik III - Universitaetsklinikum Erlangen | |
| Erlangen, Germany, D-91054 | |
| Medizinische Poliklinik | |
| Bonn, Germany, D-53111 | |
| Medizinische Universitaetsklinik I at the University of Cologne | |
| Cologne, Germany | |
| Medizinische Universitaetsklinik und Poliklinik | |
| Heidelberg, Germany, 69115 | |
| Michael Schaefers und Partner | |
| Duisburg, Germany, D-47051 | |
| Onkolog - Haematolog Schwerpunktpraxis | |
| Berlin, Germany, D-10559 | |
| Onkolog Gemeinschaftspraxis | |
| Frankfurt, Germany, 60389 | |
| Onkologische Schwerpunkt Praxis | |
| Erlangen, Germany, D-91052 | |
| Onkologische Schwerpunktpraxis - Leer | |
| Leer, Germany, D-26789 | |
| Onkologische Schwerpunktpraxis Bielefeld | |
| Bielefeld, Germany, D-33602 | |
| Onkologische Schwerpunktpraxis Lueneburg | |
| Lueneburg, Germany, D-21391 | |
| Onkologische Schwerpunktpraxis | |
| Cottbus, Germany, D-03046 | |
| Onkologischer Schwerpunkt Lerchenfeld | |
| Hamburg, Germany, D-22081 | |
| Paracelsus - Klinik Osnabrueck | |
| Osnabrueck, Germany, D-49076 | |
| Philipps-Universitaet Marburg Klinikum | |
| Marburg, Germany, D-35033 | |
| Praxis am Evangelischen Krankenhaus Bethanien | |
| Iserlohn, Germany, D-58644 | |
| Praxis DR. J. Weniger | |
| Erfurt, Germany, D-99085 | |
| St. Marien - Krankenhaus Siegen GMBH | |
| Siegen, Germany, D-57072 | |
| Praxis fuer Haematologie und Interne Onkologie | |
| Norderstedt, Germany, 22844 | |
| Praxis Fuer Haematologie/Onkologie | |
| Luebeck, Germany, D-23560 | |
| Praxis Fuer Haemotologie Und Internistischer Onkologie | |
| Wuppertal, Germany, 42105 | |
| Praxis fuer Innere Medizin und Haematologie | |
| Munich, Germany, D-80797 | |
| Praxis Fuer Internistische Haematologie / Onkologie | |
| Troisdorf, Germany, 53840 | |
| Praxis Gemeinschaft | |
| Cologne, Germany, D-50676 | |
| Prosper-Hospital Recklinghausen | |
| Recklinghausen, Germany, D-45659 | |
| Trier, Germany, D-54290 | |
| Robert-Bosch-Krankenhaus | |
| Stuttgart, Germany, 70376 | |
| Ruppiner Klinikum GMBH | |
| Neuruppin, Germany, 16816 | |
| Saechsische Schweiz Klinik | |
| Sebnitz, Germany, D-01855 | |
| Schwerpunktpraxis fuer Haematologie und Onkologie | |
| Saarbruecken, Germany, D-66113 | |
| Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie | |
| Tuebingen, Germany, D-72072 | |
| Southwest German Cancer Center at Eberhard-Karls-University | |
| Tuebingen, Germany, D-72076 | |
| St Marienkrankenhaus | |
| Ludwigshafen, Rhein, Germany, D-67067 | |
| St. Antonius Hospital | |
| Eschweiler, Germany, DOH-52249 | |
| St. Elisabeth Krankenhaus | |
| Ravensburg, Germany, 88212 | |
| St. Hedwig Kranken Haus | |
| Berlin, Germany, 10115 | |
| St. Irmgardis Krankenhaus | |
| Viersen-Suechteln, Germany, 41749 | |
| St. Johannes Hospital - Medical Klinik II | |
| Duisburg, Germany, D-47166 | |
| St. Joseph Hospital | |
| Bremerhaven, Germany, D-27568 | |
| Praxis Fuer Haematologie Internistische Onkologie | |
| Cologne, Germany, D-50677 | |
| St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH | |
| Hagen, Germany, D-58095 | |
| St. Marien-Hospital Hamm - Klinik Knappenstrasse | |
| Hamm, Germany, D-59071 | |
| St. Vincentius-Kliniken | |
| Karlsruhe, Germany, D-76137 | |
| St. Willehad Hospital | |
| Wilhelmshaven, Germany, D-26382 | |
| Stadt. KH Dresden - Neustadt | |
| Dresden, Germany, 01129 | |
| Staedt Krankenhaus | |
| Sebnitz, Germany, D-01855 | |
| Staedtisches Klinikum Braunschweig | |
| Braunschweig, Germany, D-38114 | |
| Staedtisches Klinikum Karlsruhe gGmbH | |
| Karlsruhe, Germany, 76133 | |
| Staedtisches Krankenhaus Muenchen - Harlaching | |
| Munich, Germany, D-81545 | |
| Staedtisches Krankenhaus | |
| Pforzheim, Germany, 75175 | |
| Tumorzentrum Berlin-Moabit | |
| Berlin, Germany, 10967 | |
| Universitaets - Kinderpoliklinik | |
| Muenchen, Germany, 80336 | |
| Munich, Germany, 80637 | |
| Universitaetsklinikum des Saarlandes | |
| Homburg, Germany, 66424 | |
| Universitaetsklinikum Duesseldorf | |
| Duesseldorf, Germany, D-40225 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45122 | |
| Universitaetsklinikum Freiburg | |
| Freiburg, Germany, D-79106 | |
| Universitaetsklinikum Goettingen | |
| Goettingen, Germany, D-37075 | |
| Universitaetsklinikum Hamburg-Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Universitaetsklinikum Ulm | |
| Ulm, Germany, D-89081 | |
| University Hospital Schleswig-Holstein - Kiel Campus | |
| Kiel, Germany, D-24105 | |
| Urologische Klinik - Universitaetsklinikum Aachen | |
| Aachen, Germany, D-52074 | |
| Vinzentiuskrankenhaus | |
| Landau, Germany, D-76829 | |
| Universitaetsklinikum Bonn | |
| Bonn, Germany, D-53105 | |
| Wenckebach - Krankenhaus | |
| Berlin, Germany, 12099 | |
| Munich, Germany, D-81241 | |
| Zentralkrankenhaus | |
| Bremerhaven, Germany, N 27574 | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Silesian Medical Academy | |
| Katowice, Poland, 40-029 | |
| Spain | |
| Hospital Universitario Virgen de la Victoria | |
| Malaga, Spain, 29010 | |
| Switzerland | |
| Bezirksspital Dornach | |
| Dornach, Switzerland, CH-4143 | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| Facharzt FMH Fuer Innere Medizin and Oncology | |
| Baar, Switzerland, CH-6340 | |
| Facharzt Fuer Onkologie-Hematologie | |
| Bern, Switzerland, 3013 | |
| FMH f. Innere Medizin and Hematologie | |
| Grosshochstetten, Switzerland, 3506 | |
| Hopital Cantonal Universitaire de Geneve | |
| Geneva, Switzerland, CH-1211 | |
| Basel, Switzerland, CH 4051 | |
| Inselspital Bern | |
| Bern, Switzerland, CH-3010 | |
| Institut Central des Hopitaux Valaisans | |
| Sion, Switzerland, CH-1951 | |
| Kantonspital Aarau | |
| Aarau, Switzerland, CH-5001 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Kantonsspital, Luzerne | |
| Luzerne, Switzerland, CH-6016 | |
| Klinik Hirslanden | |
| Zurich, Switzerland, CH-8008 | |
| Oncology Institute of Southern Switzerland | |
| Bellinzona, Switzerland, CH-6500 | |
| UniversitaetsSpital Zuerich | |
| Zurich, Switzerland, CH-8091 | |
| Universitaetsspital-Basel | |
| Basel, Switzerland, CH-4031 | |
| Inneremedizin FMH | |
| Breitenbach, Switzerland, 4226 | |
| Study Chair: | Ruediger Hehlmann, MD | III. Medizinische Klinik Mannheim |
More Information
| Study ID Numbers: | CDR0000068957, III-MK-CML-3A, EU-20118 |
| Study First Received: | October 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00025402 History of Changes |
| Health Authority: | United States: Federal Government |
|
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia Philadelphia chromosome negative chronic myelogenous leukemia childhood chronic myelogenous leukemia atypical chronic myeloid leukemia |
|
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hydroxyurea Hematologic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Leukemia Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Alkylating Agents Etoposide Nucleic Acid Synthesis Inhibitors Cytarabine Interferon-alpha Antisickling Agents Neoplasms by Histologic Type Hematologic Diseases Growth Substances Interferons Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Immunosuppressive Agents |
