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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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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

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Study Design

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


Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00055874


  Show 66 Study Locations
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 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20248
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
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