Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia

NCT00025402 | Unknown Phase 3

• 3 other identifiers: CDR0000068957III-MK-CML-3AEU-20118
• Study Type: interventional
• Target: 1,000
• Locations: 5 countries
• Sites: 188

Brief Summary

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.

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive; Philadelphia chromosome negative chronic myelogenous leukemia; childhood chronic myelogenous leukemia; atypical chronic myeloid leukemia, BCR-ABL1 negative

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

filgrastim BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

busulfan DRUG

cyclophosphamide DRUG

cytarabine DRUG

etoposide DRUG

hydroxyurea DRUG

idarubicin DRUG

allogeneic bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia in chronic phase * Previously untreated * Patients negative for Philadelphia chromosome and BCR-ABL translocation must fulfill at least 1 of the following criteria: * Impaired health status with reduced exercise tolerance * Spleen-related symptoms in cases of splenomegaly * Weight loss greater than 10% in 6 months * Fever greater than 38.5 degrees C on 5 consecutive days * Clinically relevant bone pain * Leukocytosis greater than 5,000/mm\^3 * Thrombocytosis greater than 100,000/mm\^3 PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Other: * No other concurrent malignancy that is likely to require treatment during study or that is likely to reduce life expectancy * No severe concurrent disease or other cause that would preclude study * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interferon Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• III. Medizinische Klinik Mannheim: lead

Study Sites (188)

Masaryk University Hospital

Brno, 62500, Czechia

Location

Haematologisch Onkologische Praxis

Aachen, D-52070, Germany

Location

Kinderklinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Urologische Klinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Kreiskrankenhaus

Aalen, 73430, Germany

Location

Klinikum St. Marien

Amberg, D-92224, Germany

Location

Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

Ansbach, 91522, Germany

Location

II. Medizinische Klinik

Aschaffenburg, RG 63739, Germany

Location

Haematologische Praxis

Augsburg, 86150, Germany

Location

Klinikum Augsburg

Augsburg, DOH-86156, Germany

Location

Kreiskrankenhaus

Bad Hersfeld, 36251, Germany

Location

Krankenhaus Hohe Warte Mediziniche Klinik

Bayreuth, 95445, Germany

Location

St. Hedwig Kranken Haus

Berlin, 10115, Germany

Location

Tumorzentrum Berlin-Moabit

Berlin, 10967, Germany

Location

Wenckebach - Krankenhaus

Berlin, 12099, Germany

Location

Helios Klinikum Berlin

Berlin, 13125, Germany

Location

Haematologisch-Onkologische Schwerpunktpraxis

Berlin, 13357, Germany

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Onkolog - Haematolog Schwerpunktpraxis

Berlin, D-10559, Germany

Location

Krankenhaus Neukoelln

Berlin, D-12313, Germany

Location

Charite - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Kinderklinik der Freier Universitaet Berlin

Berlin, D-14059, Germany

Location

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, D-33602, Germany

Location

Franziskus Hospital

Bietigheim, 74321, Germany

Location

Krankenhaus Bietigheim

Bietigheim, 74321, Germany

Location

Europahochhaus

Bochum, 44787, Germany

Location

Universitaetsklinikum Bonn

Bonn, D-53105, Germany

Location

Medizinische Poliklinik

Bonn, D-53111, Germany

Location

Marienhospital Bottrop gGmbH

Bottrop, D-46236, Germany

Location

Kreiskrankenhaus Boeblingen

Böblingen, 71032, Germany

Location

Staedtisches Klinikum Braunschweig

Braunschweig, D-38114, Germany

Location

Klinikum Bremen-Mitte

Bremen, D-28205, Germany

Location

St. Joseph Hospital

Bremerhaven, D-27568, Germany

Location

Zentralkrankenhaus

Bremerhaven, N 27574, Germany

Location

Medizinische Klinik Am Lukas - Krankenhaus

Bünde, 32257, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Praxis Gemeinschaft

Cologne, D-50676, Germany

Location

Praxis Fuer Haematologie Internistische Onkologie

Cologne, D-50677, Germany

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, Germany

Location

Onkologische Schwerpunktpraxis

Cottbus, D-03046, Germany

Location

Stadt. KH Dresden - Neustadt

Dresden, 01129, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Michael Schaefers und Partner

Duisburg, D-47051, Germany

Location

St. Johannes Hospital - Medical Klinik II

Duisburg, D-47166, Germany

Location

Krankenhaus Dueren

Düren, 52351, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, D-40225, Germany

Location

Hans - Susemihl - Krankenhaus

Emden, 26721, Germany

Location

Internistiche Praxis

Erfurt, 99084, Germany

Location

Klinikum Erfurt

Erfurt, 99089, Germany

Location

Praxis DR. J. Weniger

Erfurt, D-99085, Germany

Location

Onkologische Schwerpunkt Praxis

Erlangen, D-91052, Germany

Location

Medizinische Klinik III - Universitaetsklinikum Erlangen

Erlangen, D-91054, Germany

Location

St. Antonius Hospital

Eschweiler, DOH-52249, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Evangelisches Krankenhaus Essen Werden

Essen, D-45239, Germany

Location

Malteser Krankenhaus

Flensburg, D-24939, Germany

Location

Onkolog Gemeinschaftspraxis

Frankfurt, 60389, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

II Medizinische Klinik - Klinikum Fuerth

Fürth, D-90766, Germany

Location

Kreiskrankenhaus Fuessen

Füssen, 87629, Germany

Location

Klinikum Garmisch - Partenkirchen GmbH

Garmisch-Partenkirchen, D-82467, Germany

Location

Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

Giessen, 35392, Germany

Location

Klinik und Poliklinik fuer Urologie und Kinderurologie

Giessen, D-35392, Germany

Location

DR Herbert - Nieper Krankenhaus Goslar

Goslar, 38642, Germany

Location

Klinik fuer Radioonkologie und Strahlentherapie

Göppingen, 73035, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Allgemeines Krankenhaus Hagen

Hagen, D-58095, Germany

Location

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, D-58095, Germany

Location

Allgemeines Krankenhaus Altona

Hamburg, 22763, Germany

Location

Hermann - Holthusen Institute for Radiotherapy

Hamburg, D-20099, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, D-20246, Germany

Location

Onkologischer Schwerpunkt Lerchenfeld

Hamburg, D-22081, Germany

Location

Asklepios Klinik Barmbek

Hamburg, D-22291, Germany

Location

Haematologisch-Onkologische Praxis Altona

Hamburg, D-22767, Germany

Location

Evangelische Krankenhaus Hamm

Hamm, D-59063, Germany

Location

St. Marien-Hospital Hamm - Klinik Knappenstrasse

Hamm, D-59071, Germany

Location

Haematologie Und Internistische Onkologie

Hanau, 63450, Germany

Location

Krankenhaus Siloah - Medizinische Klinik II

Hanover, D-30449, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Medizinische Universitaetsklinik und Poliklinik

Heidelberg, 69115, Germany

Location

Klinikum Herford

Herford, D-32049, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, 66424, Germany

Location

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, D-55743, Germany

Location

Praxis am Evangelischen Krankenhaus Bethanien

Iserlohn, D-58644, Germany

Location

Klinikum der Friedrich-Schiller Universitaet Jena

Jena, D-07740, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

Gemeinschaftspraxis Brunoehler

Karlsruhe, 76135, Germany

Location

St. Vincentius-Kliniken

Karlsruhe, D-76137, Germany

Location

Diakonissen - Krankenhaus

Karlsruhe-Rueppur, 76199, Germany

Location

Klinikum Kassel

Kassel, D-34125, Germany

Location

Klinikum Kempten Oberallgaeu

Kempten, D-87439, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Klinik Konstanz

Konstanz, 78461, Germany

Location

Haematologische / Onkologische Schwerpunktpraxis

Krefeld, 47798, Germany

Location

Klinikum Krefeld GmbH

Krefeld, D-47805, Germany

Location

Vinzentiuskrankenhaus

Landau, D-76829, Germany

Location

Caritas - Krakenhaus Lebach

Lebach, 66822, Germany

Location

Onkologische Schwerpunktpraxis - Leer

Leer, D-26789, Germany

Location

Klinikum Lippe - Lemgo

Lemgo, D-32657, Germany

Location

Luisenkrankenhaus

Lindenfels, 64678, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen am Rhein, D-67063, Germany

Location

St Marienkrankenhaus

Ludwigshafen, Rhein, D-67067, Germany

Location

Praxis Fuer Haematologie/Onkologie

Lübeck, D-23560, Germany

Location

Onkologische Schwerpunktpraxis Lueneburg

Lüneburg, D-21391, Germany

Location

Gemeinschaftspraxis

Mannheim, D-68161, Germany

Location

III Medizinische Klinik Mannheim

Mannheim, D-68305, Germany

Location

Philipps-Universitaet Marburg Klinikum

Marburg, D-35033, Germany

Location

Kreiskrankenhaus Mellrichstadt

Mellrichstad, DT-97638, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

Krankenhaus Maria Hilf GmbH

Mönchengladbach, DOH-41063, Germany

Location

Gemeinschaftspraxis

Munich, 80331, Germany

Location

Unknown Facility

Munich, 80637, Germany

Location

Krankenhaus Muenchen Schwabing

Munich, 80804, Germany

Location

Medizinische Kl. Klinikum Innenstadt Universitaet Muenchen

Munich, D-80336, Germany

Location

Praxis fuer Innere Medizin und Haematologie

Munich, D-80797, Germany

Location

Unknown Facility

Munich, D-81241, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, D-81545, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Krankenhaus Muenchen Neuperlach

Munich, D-81737, Germany

Location

Universitaets - Kinderpoliklinik

München, 80336, Germany

Location

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

Münster, D-48129, Germany

Location

Ruppiner Klinikum GMBH

Neuruppin, 16816, Germany

Location

Gemeinschaftspraxis

Niddatel-IIbenstadt, 61194, Germany

Location

Praxis fuer Haematologie und Interne Onkologie

Norderstedt, 22844, Germany

Location

Gemeinschaftspraxis

Nuremberg, D-90402, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Klinikum Nuernberg - Klinikum Sued

Nuremberg, D-90471, Germany

Location

Hematologische Praxis

Oldenburg, 26121, Germany

Location

Klinikum Oldenburg

Oldenburg, D-26133, Germany

Location

Paracelsus - Klinik Osnabrueck

Osnabrück, D-49076, Germany

Location

Staedtisches Krankenhaus

Pforzheim, 75175, Germany

Location

Kreiskrankenhaus Radebeul

Radebeul, D-01445, Germany

Location

St. Elisabeth Krankenhaus

Ravensburg, 88212, Germany

Location

Prosper-Hospital Recklinghausen

Recklinghausen, D-45659, Germany

Location

Hematologische Onkologische Praxis

Regensburg, 93047, Germany

Location

Krankenhaus Barmherzige Brueder Regensburg

Regensburg, D-93049, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, D-93053, Germany

Location

Klinikum Remscheid GmbH

Remscheid, D-42859, Germany

Location

Jakobi Krankenhaus

Rheine, 48431, Germany

Location

Caritasklinik St. Theresia

Saarbrücken, D-66113, Germany

Location

Schwerpunktpraxis fuer Haematologie und Onkologie

Saarbrücken, D-66113, Germany

Location

Saechsische Schweiz Klinik

Sebnitz, D-01855, Germany

Location

Staedt Krankenhaus

Sebnitz, D-01855, Germany

Location

St. Marien - Krankenhaus Siegen GMBH

Siegen, D-57072, Germany

Location

Kreiskrankenhaus Siegen

Siegen, D-57076, Germany

Location

Klinikum Der Hansestadt Stralsund - Klin. West

Stralsund, D-18410, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Haematologische Praxis

Stuttgart, D-70173, Germany

Location

Klinik fuer Onkologie - Katharinenhospital Stuttgart

Stuttgart, D-70174, Germany

Location

Diakonie Klinikum Stuttgart

Stuttgart, D-70176, Germany

Location

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, D-54219, Germany

Location

Unknown Facility

Trier, D-54290, Germany

Location

Praxis Fuer Internistische Haematologie / Onkologie

Troisdorf, 53840, Germany

Location

Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie

Tübingen, D-72072, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Bundeswehr Krakenhaus

Ulm, D-89070, Germany

Location

Universitaetsklinikum Ulm

Ulm, D-89081, Germany

Location

St. Irmgardis Krankenhaus

Viersen-Suechteln, 41749, Germany

Location

Klinikum Der Stadt Villingen - Schwenningen

Villingen-Schwenningen, D-78054, Germany

Location

Krankenhaus St. Michael

Voeklingen, 66333, Germany

Location

Kreiskrankenhaus

Waldroel, 51545, Germany

Location

Deutsche Klinik fuer Diagnostik

Wiesbaden, D-65191, Germany

Location

St. Willehad Hospital

Wilhelmshaven, D-26382, Germany

Location

Praxis Fuer Haemotologie Und Internistischer Onkologie

Wuppertal, 42105, Germany

Location

Helios Kliniken Wuppertal University Hospital

Wuppertal, D-42283, Germany

Location

Kliniken St. Antonius

Wuppertal, D-42283, Germany

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Silesian Medical Academy

Katowice, 40-029, Poland

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Facharzt FMH Fuer Innere Medizin and Oncology

Baar, CH-6340, Switzerland

Location

Unknown Facility

Basel, CH 4051, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Facharzt Fuer Onkologie-Hematologie

Bern, 3013, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Inneremedizin FMH

Breitenbach, 4226, Switzerland

Location

Bezirksspital Dornach

Dornach, CH-4143, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

FMH f. Innere Medizin and Hematologie

Gross Höchstetten, 3506, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital, Luzerne

Luzerne, CH-6016, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Institut Central des Hopitaux Valaisans

Sion, CH-1951, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Filgrastim; Interferon-alpha; Busulfan; Cyclophosphamide; Cytarabine; Etoposide; Hydroxyurea; Idarubicin; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interferon Type I; Interferons; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Urea; Amides; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Ruediger Hehlmann, MD

  III. Medizinische Klinik Mannheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 1997
• Last Updated: December 18, 2013

Record last verified: 2002-07

Locations

PL (2); CZ (1); DE (167); ES (1); CH (17)