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

This study is currently recruiting participants.
Verified November 2011 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00055874
First received: March 6, 2003
Last updated: August 9, 2013
Last verified: November 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Risk group-dependent survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Hematologic, cytogenetic, and molecular response rates [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse drug effects [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: June 2002
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior interferon

Chemotherapy

  • No prior chemotherapy other than hydroxyurea

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Other

  • Prior anagrelide allowed
  • No participation in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055874

  Hide Study Locations
Locations
Germany
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    langer@kkh-aurich.de   
Kreiskrankenhaus Recruiting
Bad Hersfeld, Germany, 36251
Contact: P J Majunke, MD    49-6621-881779      
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie Recruiting
Berlin, Germany, D-10117
Contact: Christian Sperling, MD    49-30-2804-1960      
Haematologisch-Onkologische Schwerpunktpraxis Recruiting
Berlin, Germany, 13357
Contact: Ilona Blau, MD    49-30-461-4857      
St. Hedwig Krankenhaus Recruiting
Berlin, Germany, 10115
Contact: Christian Boewer, MD    49-30-2311-2255      
Gemeinschaftspraxis fuer Haematologie und Internistische Onkologie Recruiting
Berlin, Germany, D-12103
Contact: Friedrich Ludwig, MD    49-30-757-047-20    onkopraxis-lmu@GMX.de   
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      
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Maike de Wit, MD, PhD    49-404-2803-4315      
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, D-20099
Contact: Rutjes, MD    49-40-2890-2416      
Evangelische Krankenhaus Hamm Recruiting
Hamm, Germany, DOH-59063
Contact: Leopold Balleisen, MD    49-2381-589-1333    LBalleisen@evkhamm.de   
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      
Medizinische Universitaetsklinik und Poliklinik Recruiting
Heidelberg, Germany, 69115
Contact: Anthony D. Ho, MD, PhD    49-6221-56-8001    anthony_ho@med.uni-heidelberg.de   
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    michael.pfreundschuh@uniklinik-saarland.de   
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    gerhard.goeckel@vincentius-ka.de   
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    Lothar.Mueller@onkologie-leer.de   
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    henrichd@klilu.de   
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    wehmeyer@onkologie-muenster.de   
Haematologische Schwerpunktpraxis Recruiting
Munich, Germany, D-81679
Contact: Helmut Hitz, MD    49-89-9972-0275      
Klinikum der Universitaet Muenchen - Grosshadern Campus Recruiting
Munich, Germany, D-81377
Contact: Torsten Haferlach, MD    49-89-7095-4970      
Klinikum der Universitaet Regensburg Recruiting
Regensburg, Germany, D-93042
Contact: Stefan W. Krause, MD    49-941-944-5538      
Hematologische Onkologische Praxis Recruiting
Regensburg, Germany, 93047
Contact: Robert Dengler, MD    49-941-566-342    robert.dougler@t-online.de   
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    tgeer@diaksha.de   
Kreiskrankenhaus Siegen Recruiting
Siegen, Germany, D-57076
Contact: Schulz, MD    49-271-705-0      
St. Marien - Krankenhaus Siegen GMBH Recruiting
Siegen, Germany, D-57072
Contact: Winfried Gassmann, MD    0271 231 2260      
Hanse-Klinikum Stralsund - Krankenhaus West Recruiting
Stralsund, Germany, D-18410
Contact: Thomas Heinz Ittel, MD    49-3831-35-2700    medizinische.klinik@klinikum-stralsund.de   
Onkologische Schwerpunktpraxis - Straubing Recruiting
Straubing, Germany, 94315
Contact: Matthias Demandt, MD    49-9421-90777      
Klinik fuer Onkologie - Katharinenhospital Stuttgart Recruiting
Stuttgart, Germany, D-70174
Contact: Hans-Guenther Mergenthaler, MD    49-711-278-5601    h.mergenthaler@katharinehospital.de   
Diakonie Klinikum Stuttgart Recruiting
Stuttgart, Germany, D-70176
Contact: Else G. Heidemann, MD    49-711-991-3501      
Haematologische Praxis Recruiting
Stuttgart, Germany, D-70173
Contact: Gregor Springer, MD    49-711-222-0244      
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Walter Aulitzky, MD    49-711-8101-3506    walter.aulitzky@rbk.de   
Recruiting
Trier, Germany, D-54290
Contact: Bernhard Rendenbach, MD    49-651-493-93    info@straurenlau.de   
Southwest German Cancer Center at Eberhard-Karls-University Recruiting
Tuebingen, Germany, D-72076
Contact: Tim Henrik Brummendorf, MD    49-7071-298-0648    tim.bruemmendorf@med.uni-tuebingen.de   
Schwerpunktpraxis fuer Rheumatologie und Haematologie/Internistische Onkologie Recruiting
Tuebingen, Germany, D-72072
Contact: Swen H. Jacki, MD    49-7071-567-888      
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    fett-onkologe@t-online.de   
Helios Kliniken Wuppertal University Hospital Recruiting
Wuppertal, Germany, D-42283
Contact: Aruna Raghavachar, MD, PhD    49-202-896-3351    araghavachar@wuppertal.helios-kliniken.de   
University Wurzburg Recruiting
Wurzburg, Germany, D-97070
Contact: M. E. Goebeler, MD    49-931-201-7080      
Hamatologisch - Onkologische Praxis Wurzburg Recruiting
Wurzburg, Germany, 97070
Contact: Rudolf Schlag, MD    49-931-322-670      
Switzerland
Recruiting
Basel, Switzerland, CH 4051
Contact: Walter Weber-Stadelmann, MD    41-61-261-0225    cancer@bluewin.ch   
Sponsors and Collaborators
III. Medizinische Klinik Mannheim
Investigators
Study Chair: Ruediger Hehlmann, MD III. Medizinische Klinik Mannheim
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00055874     History of Changes
Other Study ID Numbers: III-MK-CML-IV, CDR0000271424, EU-20248
Study First Received: March 6, 2003
Last Updated: August 9, 2013
Health Authority: Unspecified

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
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferon-alpha
Interferon Alfa-2a
Cytarabine
Interferons
Imatinib
Hydroxyurea
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 17, 2014