Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055874
Recruitment Status : Unknown
Verified November 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 7, 2003
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, imatinib mesylate may stop the growth of cancer cells by blocking the enzymes needed for cancer cell growth. 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 which treatment regimen is most effective in treating chronic phase chronic myelogenous leukemia.

PURPOSE: This randomized phase III trial is studying imatinib mesylate with or without interferon alfa or cytarabine to see how well it works compared with interferon alfa followed by donor stem cell transplant in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: recombinant interferon alfa Drug: cytarabine Drug: hydroxyurea Drug: imatinib mesylate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Treatment Optimization Trial in Chronic Myeloid Leukemia (CML) - Randomized Controlled Comparison of Imatinib vs. Imatinib/Interferon-alpha vs. Imatinib/Low-Dose AraC vs. Interferon-alpha Standard Therapy and Determination of the Role of Allografting in Newly Diagnosed Chronic Phase
Study Start Date : June 2002
Estimated Primary Completion Date : December 2016

Primary Outcome Measures :
  1. Overall survival
  2. Risk group-dependent survival
  3. Progression-free survival
  4. Hematologic, cytogenetic, and molecular response rates

Secondary Outcome Measures :
  1. Adverse drug effects
  2. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed chronic phase chronic myelogenous leukemia (CML)

    • bcr-abl positive
    • No blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood
  • Availability of a HLA-identical sibling or unrelated donor



  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No second malignancy requiring therapy
  • No evidence of disease-related symptoms or extramedullary disease (including hepatosplenomegaly)
  • No serious diseases that would preclude study participation


Biologic therapy

  • No prior interferon


  • No prior chemotherapy other than hydroxyurea

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • Not specified


  • Prior anagrelide allowed
  • No participation in another clinical trial

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 identifier (NCT number): NCT00055874

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Krankenhaus / Klinikum Krefeld Recruiting
Aachen, Germany, 52074
Contact: Michaela Johnen, MD    49-241-736-08      
Kreiskrankenhaus Aurich Recruiting
Aurich, Germany, 26603
Contact: Langer, MD    49-4941-94-5000   
Kreiskrankenhaus Recruiting
Bad Hersfeld, Germany, 36251
Contact: P J Majunke, MD    49-6621-881779      
St. Hedwig Krankenhaus Recruiting
Berlin, Germany, 10115
Contact: Christian Boewer, MD    49-30-2311-2255      
Haematologisch-Onkologische Schwerpunktpraxis Recruiting
Berlin, Germany, 13357
Contact: Ilona Blau, MD    49-30-461-4857      
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie Recruiting
Berlin, Germany, D-10117
Contact: Christian Sperling, MD    49-30-2804-1960      
Gemeinschaftspraxis fuer Haematologie und Internistische Onkologie Recruiting
Berlin, Germany, D-12103
Contact: Friedrich Ludwig, MD    49-30-757-047-20   
Onkologische Schwerpunktpraxis Bielefeld Recruiting
Bielefeld, Germany, D-33602
Contact: Marianne Just, MD    49-521-137-930      
Augustinum Recruiting
Bonn, Germany, D-53117
Contact: Karl Grips, MD    49-228-67-38-00      
Hamatologische Sprechstunde Recruiting
Brandenburg, Germany, 14770
Contact: Fischer-Lampsatis, MD    49-3381-411-555      
Praxis Dres. F.& G. Doering Recruiting
Bremen, Germany, D-28205
Contact: Gabriele Doering, MD    49-421-498-5068      
Staedtisches Kliniken Delmenhorst Recruiting
Delmenhorst, Germany, 27753
Contact: Funke, MD    49-4221-994-101      
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45122
Contact: Ulrich Duehrsen    49-201-723-2417      
Evangelisches Krankenhaus Essen Werden Recruiting
Essen, Germany, D-45239
Contact: Franz-Karl Baur, MD    49-201-4089-2099      
Klinikum der J.W. Goethe Universitaet Recruiting
Frankfurt, Germany, D-60590
Contact: Dieter Hoelzer, MD, PhD    49-69-6301-5194      
Internistische Praxisgemeinschaft Recruiting
Germering, Germany, 82110
Contact: Johann Mittermueller, MD    49-89-842-910      
DR Herbert - Nieper Krankenhaus Goslar Recruiting
Goslar, Germany, 38642
Contact: Andreas Hoyer, MD    49-5321-555-401      
Universitaetsklinikum Goettingen Recruiting
Gottingen, Germany, D-37075
Contact: Claudia Binder, MD, PhD    49-551-39-2331      
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH Recruiting
Hagen, Germany, D-58095
Contact: Hartmut Eimermacher, MD    49-2331-129-250      
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, D-20099
Contact: Rutjes, MD    49-40-2890-2416      
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Maike de Wit, MD, PhD    49-404-2803-4315      
Evangelische Krankenhaus Hamm Recruiting
Hamm, Germany, DOH-59063
Contact: Leopold Balleisen, MD    49-2381-589-1333   
Medizinische Universitaetsklinik und Poliklinik Recruiting
Heidelberg, Germany, 69115
Contact: Anthony D. Ho, MD, PhD    49-6221-56-8001   
Universitatsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69115
Contact: Elke Brants    49-6221-56-8006      
Ruprecht - Karls - Universitaet Heidelberg Recruiting
Heidelberg, Germany, D-69120
Contact: Stefan Fruehauf, MD    49-622-156-8085      
Medical University Hospital Homburg Recruiting
Homburg, Germany, 66421
Contact: Hans W. Pees, MD    49-6841-162-3000      
Universitaetsklinikum des Saarlandes Recruiting
Homburg, Germany, D-66424
Contact: Michael G.M. Pfreundschuh, MD    49-6841-162-3084   
Westpfalz-Klinikum GmbH Recruiting
Kaiserslautern, Germany, D-67653
Contact: Katja Buhl    49-631-203-1872      
Staedtisches Klinikum Karlsruhe gGmbH Recruiting
Karlsruhe, Germany, 76133
Contact: Contact Person    49-721-974-1390      
St. Vincentius - Kliniken Recruiting
Karlsruhe, Germany, D-76137
Contact: Gerhard Goeckel, MD    49-721-8108-3035   
Klinikum Kempten Oberallgaeu Recruiting
Kempten, Germany, 87439
Contact: Gatter, MD    49-831-530-2226      
University Hospital Schleswig-Holstein - Kiel Campus Recruiting
Kiel, Germany, D-24116
Contact: Robert Schoch, MD    49-431-1697-5226      
Klinikum Krefeld GmbH Recruiting
Krefeld, Germany, D-47805
Contact: Sabine Helmer, MD    49-2151-32-2709      
Internistisches Fachaerzte Zentrum Langen Recruiting
Langen, Germany, D-63225
Contact: Andreas Koehler, MD    49-61-032-8787      
Caritas - Krakenhaus Lebach Recruiting
Lebach, Germany, 66822
Contact: Harald Jost, MD    49-6881-501-273      
Onkologische Schwerpunktpraxis - Leer Recruiting
Leer, Germany, D-26789
Contact: Lothar Mueller, MD    49-491-987-910   
Klinikum Lippe - Lemgo Recruiting
Lemgo, Germany, D-32657
Contact: Contact Person    49-52-6126-4123      
Klinikum der Stadt Ludwigshafen am Rhein Recruiting
Ludwigshafen am Rhein, Germany, D-67063
Contact: Henrich, MD    49-621-503-3900   
III Medizinische Klinik Mannheim Recruiting
Mannheim, Germany, D-68305
Contact: Michael Schatz, MD    49-621-383-4114      
Hospital Maria-Hilf II Recruiting
Monchengladbach, Germany, D-41063
Contact: Lange, MD    49-2161-892-2212      
Krankenhaus Muenchen Schwabing Recruiting
Muenchen, Germany, 80804
Contact: Christof Fischer, MD    49-89-3068-2389      
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster Recruiting
Muenster, Germany, D-48149
Contact: Juergen Wehmeyer, MD    49-251-620-080   
Klinikum der Universitaet Muenchen - Grosshadern Campus Recruiting
Munich, Germany, D-81377
Contact: Torsten Haferlach, MD    49-89-7095-4970      
Haematologische Schwerpunktpraxis Recruiting
Munich, Germany, D-81679
Contact: Helmut Hitz, MD    49-89-9972-0275      
Hematologische Onkologische Praxis Recruiting
Regensburg, Germany, 93047
Contact: Robert Dengler, MD    49-941-566-342   
Klinikum der Universitaet Regensburg Recruiting
Regensburg, Germany, D-93042
Contact: Stefan W. Krause, MD    49-941-944-5538      
Klinikum Remscheid GmbH Recruiting
Remscheid, Germany, D-42859
Contact: Arthur Wehmeier, MD    49-21-9113-4700      
Internistische Schwerpunktpraxis Recruiting
Russelsheim, Germany, 65428
Contact: M. Baldus, MD    49-6142-940-321      
Diakonie - Krankenhaus Recruiting
Schwaebisch Hall, Germany, 74523
Contact: Thomas Geer, MD    49-791-753-4411   
St. Marien - Krankenhaus Siegen GMBH Recruiting
Siegen, Germany, D-57072
Contact: Winfried Gassmann, MD    0271 231 2260      
Kreiskrankenhaus Siegen Recruiting
Siegen, Germany, D-57076
Contact: Schulz, MD    49-271-705-0      
Hanse-Klinikum Stralsund - Krankenhaus West Recruiting
Stralsund, Germany, D-18410
Contact: Thomas Heinz Ittel, MD    49-3831-35-2700   
Onkologische Schwerpunktpraxis - Straubing Recruiting
Straubing, Germany, 94315
Contact: Matthias Demandt, MD    49-9421-90777      
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Walter Aulitzky, MD    49-711-8101-3506   
Haematologische Praxis Recruiting
Stuttgart, Germany, D-70173
Contact: Gregor Springer, MD    49-711-222-0244      
Klinik fuer Onkologie - Katharinenhospital Stuttgart Recruiting
Stuttgart, Germany, D-70174
Contact: Hans-Guenther Mergenthaler, MD    49-711-278-5601   
Diakonie Klinikum Stuttgart Recruiting
Stuttgart, Germany, D-70176
Contact: Else G. Heidemann, MD    49-711-991-3501      
Trier, Germany, D-54290
Contact: Bernhard Rendenbach, MD    49-651-493-93   
Schwerpunktpraxis fuer Rheumatologie und Haematologie/Internistische Onkologie Recruiting
Tuebingen, Germany, D-72072
Contact: Swen H. Jacki, MD    49-7071-567-888      
Southwest German Cancer Center at Eberhard-Karls-University Recruiting
Tuebingen, Germany, D-72076
Contact: Tim Henrik Brummendorf, MD    49-7071-298-0648   
Haematologische Praxis Recruiting
Weiden, Germany, D-92637
Contact: Johann Weiss, MD    49-961-320-60      
Praxis Fuer Haemotologie Und Internistischer Onkologie Recruiting
Wuppertal, Germany, 42105
Contact: Werner Fett, MD    49-202-449-232   
Helios Kliniken Wuppertal University Hospital Recruiting
Wuppertal, Germany, D-42283
Contact: Aruna Raghavachar, MD, PhD    49-202-896-3351   
Hamatologisch - Onkologische Praxis Wurzburg Recruiting
Wurzburg, Germany, 97070
Contact: Rudolf Schlag, MD    49-931-322-670      
University Wurzburg Recruiting
Wurzburg, Germany, D-97070
Contact: M. E. Goebeler, MD    49-931-201-7080      
Basel, Switzerland, CH 4051
Contact: Walter Weber-Stadelmann, MD    41-61-261-0225   
Sponsors and Collaborators
III. Medizinische Klinik Mannheim
Study Chair: Ruediger Hehlmann, MD III. Medizinische Klinik Mannheim

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00055874     History of Changes
Other Study ID Numbers: III-MK-CML-IV
CDR0000271424 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: November 2011

Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Antisickling Agents
Nucleic Acid Synthesis Inhibitors