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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055874

  Hide Study Locations
Locations
Germany
Krankenhaus / Klinikum Krefeld
Aachen, Germany, 52074
Kreiskrankenhaus Aurich
Aurich, Germany, 26603
Kreiskrankenhaus
Bad Hersfeld, Germany, 36251
St. Hedwig Krankenhaus
Berlin, Germany, 10115
Haematologisch-Onkologische Schwerpunktpraxis
Berlin, Germany, 13357
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie
Berlin, Germany, D-10117
Gemeinschaftspraxis fuer Haematologie und Internistische Onkologie
Berlin, Germany, D-12103
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany, D-33602
Augustinum
Bonn, Germany, D-53117
Hamatologische Sprechstunde
Brandenburg, Germany, 14770
Praxis Dres. F.& G. Doering
Bremen, Germany, D-28205
Staedtisches Kliniken Delmenhorst
Delmenhorst, Germany, 27753
Universitaetsklinikum Essen
Essen, Germany, D-45122
Evangelisches Krankenhaus Essen Werden
Essen, Germany, D-45239
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Internistische Praxisgemeinschaft
Germering, Germany, 82110
DR Herbert - Nieper Krankenhaus Goslar
Goslar, Germany, 38642
Universitaetsklinikum Goettingen
Gottingen, Germany, D-37075
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, Germany, D-58095
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Evangelische Krankenhaus Hamm
Hamm, Germany, DOH-59063
Medizinische Universitaetsklinik und Poliklinik
Heidelberg, Germany, 69115
Universitatsklinikum Heidelberg
Heidelberg, Germany, 69115
Ruprecht - Karls - Universitaet Heidelberg
Heidelberg, Germany, D-69120
Medical University Hospital Homburg
Homburg, Germany, 66421
Universitaetsklinikum des Saarlandes
Homburg, Germany, D-66424
Westpfalz-Klinikum GmbH
Kaiserslautern, Germany, D-67653
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany, 76133
St. Vincentius - Kliniken
Karlsruhe, Germany, D-76137
Klinikum Kempten Oberallgaeu
Kempten, Germany, 87439
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24116
Klinikum Krefeld GmbH
Krefeld, Germany, D-47805
Internistisches Fachaerzte Zentrum Langen
Langen, Germany, D-63225
Caritas - Krakenhaus Lebach
Lebach, Germany, 66822
Onkologische Schwerpunktpraxis - Leer
Leer, Germany, D-26789
Klinikum Lippe - Lemgo
Lemgo, Germany, D-32657
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, Germany, D-67063
III Medizinische Klinik Mannheim
Mannheim, Germany, D-68305
Hospital Maria-Hilf II
Monchengladbach, Germany, D-41063
Krankenhaus Muenchen Schwabing
Muenchen, Germany, 80804
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
Muenster, Germany, D-48149
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Haematologische Schwerpunktpraxis
Munich, Germany, D-81679
Hematologische Onkologische Praxis
Regensburg, Germany, 93047
Klinikum der Universitaet Regensburg
Regensburg, Germany, D-93042
Klinikum Remscheid GmbH
Remscheid, Germany, D-42859
Internistische Schwerpunktpraxis
Russelsheim, Germany, 65428
Diakonie - Krankenhaus
Schwaebisch Hall, Germany, 74523
St. Marien - Krankenhaus Siegen GMBH
Siegen, Germany, D-57072
Kreiskrankenhaus Siegen
Siegen, Germany, D-57076
Hanse-Klinikum Stralsund - Krankenhaus West
Stralsund, Germany, D-18410
Onkologische Schwerpunktpraxis - Straubing
Straubing, Germany, 94315
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Haematologische Praxis
Stuttgart, Germany, D-70173
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, Germany, D-70174
Diakonie Klinikum Stuttgart
Stuttgart, Germany, D-70176
Trier, Germany, D-54290
Schwerpunktpraxis fuer Rheumatologie und Haematologie/Internistische Onkologie
Tuebingen, Germany, D-72072
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany, D-72076
Haematologische Praxis
Weiden, Germany, D-92637
Praxis Fuer Haemotologie Und Internistischer Onkologie
Wuppertal, Germany, 42105
Helios Kliniken Wuppertal University Hospital
Wuppertal, Germany, D-42283
Hamatologisch - Onkologische Praxis Wurzburg
Wurzburg, Germany, 97070
University Wurzburg
Wurzburg, Germany, D-97070
Switzerland
Basel, Switzerland, CH 4051
Sponsors and Collaborators
III. Medizinische Klinik Mannheim
Investigators
Study Chair: Ruediger Hehlmann, MD III. Medizinische Klinik Mannheim
  More Information

Publications:
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
Interferons
Cytarabine
Imatinib Mesylate
Hydroxyurea
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Antisickling Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2017