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| ID | Type | Description | Link |
|---|---|---|---|
| III-MK-CML-3A | |||
| EU-20118 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| recombinant interferon alfa | Biological | |||
| busulfan | Drug | |||
| cyclophosphamide | Drug | |||
| cytarabine | Drug | |||
| etoposide | Drug | |||
| hydroxyurea | Drug | |||
| idarubicin |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | ||
| Frequency, time-point, and duration of hematologic and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCL-ABL-positive cells | ||
| Correlation of quality of hematological and cytogenetic remission with survival time | ||
| Course of the terminal phase | ||
| Toxicity | ||
| Effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time | ||
| Effect of early vs late high-dose therapy and autografting on feasibility, toxicity and survival times |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ruediger Hehlmann, MD | III. Medizinische Klinik Mannheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masaryk University Hospital | Brno | 62500 | Czechia | |||
| Haematologisch Onkologische Praxis |
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| Drug |
| allogeneic bone marrow transplantation | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| radiation therapy | Radiation |
| Aachen |
| D-52070 |
| Germany |
| Kinderklinik - Universitaetsklinikum Aachen | Aachen | D-52074 | Germany |
| Urologische Klinik - Universitaetsklinikum Aachen | Aachen | D-52074 | Germany |
| Kreiskrankenhaus | Aalen | 73430 | Germany |
| Klinikum St. Marien | Amberg | D-92224 | Germany |
| Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie | Ansbach | 91522 | Germany |
| II. Medizinische Klinik | Aschaffenburg | RG 63739 | Germany |
| Haematologische Praxis | Augsburg | 86150 | Germany |
| Klinikum Augsburg | Augsburg | DOH-86156 | Germany |
| Kreiskrankenhaus | Bad Hersfeld | 36251 | Germany |
| Krankenhaus Hohe Warte Mediziniche Klinik | Bayreuth | 95445 | Germany |
| St. Hedwig Kranken Haus | Berlin | 10115 | Germany |
| Tumorzentrum Berlin-Moabit | Berlin | 10967 | Germany |
| Wenckebach - Krankenhaus | Berlin | 12099 | Germany |
| Helios Klinikum Berlin | Berlin | 13125 | Germany |
| Haematologisch-Onkologische Schwerpunktpraxis | Berlin | 13357 | Germany |
| Charite - Campus Charite Mitte | Berlin | D-10117 | Germany |
| Onkolog - Haematolog Schwerpunktpraxis | Berlin | D-10559 | Germany |
| Krankenhaus Neukoelln | Berlin | D-12313 | Germany |
| Charite - Campus Virchow Klinikum | Berlin | D-13353 | Germany |
| Kinderklinik der Freier Universitaet Berlin | Berlin | D-14059 | Germany |
| Onkologische Schwerpunktpraxis Bielefeld | Bielefeld | D-33602 | Germany |
| Franziskus Hospital | Bietigheim | 74321 | Germany |
| Krankenhaus Bietigheim | Bietigheim | 74321 | Germany |
| Europahochhaus | Bochum | 44787 | Germany |
| Universitaetsklinikum Bonn | Bonn | D-53105 | Germany |
| Medizinische Poliklinik | Bonn | D-53111 | Germany |
| Marienhospital Bottrop gGmbH | Bottrop | D-46236 | Germany |
| Kreiskrankenhaus Boeblingen | Böblingen | 71032 | Germany |
| Staedtisches Klinikum Braunschweig | Braunschweig | D-38114 | Germany |
| Klinikum Bremen-Mitte | Bremen | D-28205 | Germany |
| St. Joseph Hospital | Bremerhaven | D-27568 | Germany |
| Zentralkrankenhaus | Bremerhaven | N 27574 | Germany |
| Medizinische Klinik Am Lukas - Krankenhaus | Bünde | 32257 | Germany |
| Klinikum Coburg | Coburg | 96450 | Germany |
| Praxis Gemeinschaft | Cologne | D-50676 | Germany |
| Praxis Fuer Haematologie Internistische Onkologie | Cologne | D-50677 | Germany |
| Medizinische Universitaetsklinik I at the University of Cologne | Cologne | Germany |
| Onkologische Schwerpunktpraxis | Cottbus | D-03046 | Germany |
| Stadt. KH Dresden - Neustadt | Dresden | 01129 | Germany |
| Medizinische Klinik I | Dresden | D-01307 | Germany |
| Michael Schaefers und Partner | Duisburg | D-47051 | Germany |
| St. Johannes Hospital - Medical Klinik II | Duisburg | D-47166 | Germany |
| Krankenhaus Dueren | Düren | 52351 | Germany |
| Universitaetsklinikum Duesseldorf | Düsseldorf | D-40225 | Germany |
| Hans - Susemihl - Krankenhaus | Emden | 26721 | Germany |
| Internistiche Praxis | Erfurt | 99084 | Germany |
| Klinikum Erfurt | Erfurt | 99089 | Germany |
| Praxis DR. J. Weniger | Erfurt | D-99085 | Germany |
| Onkologische Schwerpunkt Praxis | Erlangen | D-91052 | Germany |
| Medizinische Klinik III - Universitaetsklinikum Erlangen | Erlangen | D-91054 | Germany |
| St. Antonius Hospital | Eschweiler | DOH-52249 | Germany |
| Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| Evangelisches Krankenhaus Essen Werden | Essen | D-45239 | Germany |
| Malteser Krankenhaus | Flensburg | D-24939 | Germany |
| Onkolog Gemeinschaftspraxis | Frankfurt | 60389 | Germany |
| Klinikum der J.W. Goethe Universitaet | Frankfurt | D-60590 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | D-79106 | Germany |
| II Medizinische Klinik - Klinikum Fuerth | Fürth | D-90766 | Germany |
| Kreiskrankenhaus Fuessen | Füssen | 87629 | Germany |
| Klinikum Garmisch - Partenkirchen GmbH | Garmisch-Partenkirchen | D-82467 | Germany |
| Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie | Giessen | 35392 | Germany |
| Klinik und Poliklinik fuer Urologie und Kinderurologie | Giessen | D-35392 | Germany |
| DR Herbert - Nieper Krankenhaus Goslar | Goslar | 38642 | Germany |
| Klinik fuer Radioonkologie und Strahlentherapie | Göppingen | 73035 | Germany |
| Universitaetsklinikum Goettingen | Göttingen | D-37075 | Germany |
| Allgemeines Krankenhaus Hagen | Hagen | D-58095 | Germany |
| St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH | Hagen | D-58095 | Germany |
| Allgemeines Krankenhaus Altona | Hamburg | 22763 | Germany |
| Hermann - Holthusen Institute for Radiotherapy | Hamburg | D-20099 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | D-20246 | Germany |
| Onkologischer Schwerpunkt Lerchenfeld | Hamburg | D-22081 | Germany |
| Asklepios Klinik Barmbek | Hamburg | D-22291 | Germany |
| Haematologisch-Onkologische Praxis Altona | Hamburg | D-22767 | Germany |
| Evangelische Krankenhaus Hamm | Hamm | D-59063 | Germany |
| St. Marien-Hospital Hamm - Klinik Knappenstrasse | Hamm | D-59071 | Germany |
| Haematologie Und Internistische Onkologie | Hanau | 63450 | Germany |
| Krankenhaus Siloah - Medizinische Klinik II | Hanover | D-30449 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Medizinische Universitaetsklinik und Poliklinik | Heidelberg | 69115 | Germany |
| Klinikum Herford | Herford | D-32049 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | 66424 | Germany |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | Idar-Oberstein | D-55743 | Germany |
| Praxis am Evangelischen Krankenhaus Bethanien | Iserlohn | D-58644 | Germany |
| Klinikum der Friedrich-Schiller Universitaet Jena | Jena | D-07740 | Germany |
| Staedtisches Klinikum Karlsruhe gGmbH | Karlsruhe | 76133 | Germany |
| Gemeinschaftspraxis Brunoehler | Karlsruhe | 76135 | Germany |
| St. Vincentius-Kliniken | Karlsruhe | D-76137 | Germany |
| Diakonissen - Krankenhaus | Karlsruhe-Rueppur | 76199 | Germany |
| Klinikum Kassel | Kassel | D-34125 | Germany |
| Klinikum Kempten Oberallgaeu | Kempten | D-87439 | Germany |
| University Hospital Schleswig-Holstein - Kiel Campus | Kiel | D-24105 | Germany |
| Klinik Konstanz | Konstanz | 78461 | Germany |
| Haematologische / Onkologische Schwerpunktpraxis | Krefeld | 47798 | Germany |
| Klinikum Krefeld GmbH | Krefeld | D-47805 | Germany |
| Vinzentiuskrankenhaus | Landau | D-76829 | Germany |
| Caritas - Krakenhaus Lebach | Lebach | 66822 | Germany |
| Onkologische Schwerpunktpraxis - Leer | Leer | D-26789 | Germany |
| Klinikum Lippe - Lemgo | Lemgo | D-32657 | Germany |
| Luisenkrankenhaus | Lindenfels | 64678 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein | Ludwigshafen am Rhein | D-67063 | Germany |
| St Marienkrankenhaus | Ludwigshafen, Rhein | D-67067 | Germany |
| Praxis Fuer Haematologie/Onkologie | Lübeck | D-23560 | Germany |
| Onkologische Schwerpunktpraxis Lueneburg | Lüneburg | D-21391 | Germany |
| Gemeinschaftspraxis | Mannheim | D-68161 | Germany |
| III Medizinische Klinik Mannheim | Mannheim | D-68305 | Germany |
| Philipps-Universitaet Marburg Klinikum | Marburg | D-35033 | Germany |
| Kreiskrankenhaus Mellrichstadt | Mellrichstad | DT-97638 | Germany |
| Klinikum Minden | Minden | D-32423 | Germany |
| Krankenhaus Maria Hilf GmbH | Mönchengladbach | DOH-41063 | Germany |
| Gemeinschaftspraxis | Munich | 80331 | Germany |
| Munich | 80637 | Germany |
| Krankenhaus Muenchen Schwabing | Munich | 80804 | Germany |
| Medizinische Kl. Klinikum Innenstadt Universitaet Muenchen | Munich | D-80336 | Germany |
| Praxis fuer Innere Medizin und Haematologie | Munich | D-80797 | Germany |
| Munich | D-81241 | Germany |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | Munich | D-81377 | Germany |
| Staedtisches Krankenhaus Muenchen - Harlaching | Munich | D-81545 | Germany |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich | D-81675 | Germany |
| Krankenhaus Muenchen Neuperlach | Munich | D-81737 | Germany |
| Universitaets - Kinderpoliklinik | München | 80336 | Germany |
| Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster | Münster | D-48129 | Germany |
| Ruppiner Klinikum GMBH | Neuruppin | 16816 | Germany |
| Gemeinschaftspraxis | Niddatel-IIbenstadt | 61194 | Germany |
| Praxis fuer Haematologie und Interne Onkologie | Norderstedt | 22844 | Germany |
| Gemeinschaftspraxis | Nuremberg | D-90402 | Germany |
| Klinikum Nuernberg - Klinikum Nord | Nuremberg | D-90419 | Germany |
| Klinikum Nuernberg - Klinikum Sued | Nuremberg | D-90471 | Germany |
| Hematologische Praxis | Oldenburg | 26121 | Germany |
| Klinikum Oldenburg | Oldenburg | D-26133 | Germany |
| Paracelsus - Klinik Osnabrueck | Osnabrück | D-49076 | Germany |
| Staedtisches Krankenhaus | Pforzheim | 75175 | Germany |
| Kreiskrankenhaus Radebeul | Radebeul | D-01445 | Germany |
| St. Elisabeth Krankenhaus | Ravensburg | 88212 | Germany |
| Prosper-Hospital Recklinghausen | Recklinghausen | D-45659 | Germany |
| Hematologische Onkologische Praxis | Regensburg | 93047 | Germany |
| Krankenhaus Barmherzige Brueder Regensburg | Regensburg | D-93049 | Germany |
| Klinikum der Universitaet Regensburg | Regensburg | D-93053 | Germany |
| Klinikum Remscheid GmbH | Remscheid | D-42859 | Germany |
| Jakobi Krankenhaus | Rheine | 48431 | Germany |
| Caritasklinik St. Theresia | Saarbrücken | D-66113 | Germany |
| Schwerpunktpraxis fuer Haematologie und Onkologie | Saarbrücken | D-66113 | Germany |
| Saechsische Schweiz Klinik | Sebnitz | D-01855 | Germany |
| Staedt Krankenhaus | Sebnitz | D-01855 | Germany |
| St. Marien - Krankenhaus Siegen GMBH | Siegen | D-57072 | Germany |
| Kreiskrankenhaus Siegen | Siegen | D-57076 | Germany |
| Klinikum Der Hansestadt Stralsund - Klin. West | Stralsund | D-18410 | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | 70376 | Germany |
| Haematologische Praxis | Stuttgart | D-70173 | Germany |
| Klinik fuer Onkologie - Katharinenhospital Stuttgart | Stuttgart | D-70174 | Germany |
| Diakonie Klinikum Stuttgart | Stuttgart | D-70176 | Germany |
| Krankenanstalt Mutterhaus der Borromaerinnen | Trier | D-54219 | Germany |
| Trier | D-54290 | Germany |
| Praxis Fuer Internistische Haematologie / Onkologie | Troisdorf | 53840 | Germany |
| Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie | Tübingen | D-72072 | Germany |
| Southwest German Cancer Center at Eberhard-Karls-University | Tübingen | D-72076 | Germany |
| Bundeswehr Krakenhaus | Ulm | D-89070 | Germany |
| Universitaetsklinikum Ulm | Ulm | D-89081 | Germany |
| St. Irmgardis Krankenhaus | Viersen-Suechteln | 41749 | Germany |
| Klinikum Der Stadt Villingen - Schwenningen | Villingen-Schwenningen | D-78054 | Germany |
| Krankenhaus St. Michael | Voeklingen | 66333 | Germany |
| Kreiskrankenhaus | Waldroel | 51545 | Germany |
| Deutsche Klinik fuer Diagnostik | Wiesbaden | D-65191 | Germany |
| St. Willehad Hospital | Wilhelmshaven | D-26382 | Germany |
| Praxis Fuer Haemotologie Und Internistischer Onkologie | Wuppertal | 42105 | Germany |
| Helios Kliniken Wuppertal University Hospital | Wuppertal | D-42283 | Germany |
| Kliniken St. Antonius | Wuppertal | D-42283 | Germany |
| Medical University of Gdansk | Gdansk | 80-211 | Poland |
| Silesian Medical Academy | Katowice | 40-029 | Poland |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Kantonspital Aarau | Aarau | CH-5001 | Switzerland |
| Facharzt FMH Fuer Innere Medizin and Oncology | Baar | CH-6340 | Switzerland |
| Basel | CH 4051 | Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Oncology Institute of Southern Switzerland | Bellinzona | CH-6500 | Switzerland |
| Facharzt Fuer Onkologie-Hematologie | Bern | 3013 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Inneremedizin FMH | Breitenbach | 4226 | Switzerland |
| Bezirksspital Dornach | Dornach | CH-4143 | Switzerland |
| Hopital Cantonal Universitaire de Geneve | Geneva | CH-1211 | Switzerland |
| FMH f. Innere Medizin and Hematologie | Gross Höchstetten | 3506 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital, Luzerne | Luzerne | CH-6016 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Institut Central des Hopitaux Valaisans | Sion | CH-1951 | Switzerland |
| Klinik Hirslanden | Zurich | CH-8008 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016898 | Interferon-alpha |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| D006918 | Hydroxyurea |
| D015255 | Idarubicin |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D014508 | Urea |
| D000577 | Amides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided