Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With 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: NCT00025402
Recruitment Status : Unknown
Verified July 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Biological: recombinant interferon alfa Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: hydroxyurea Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia (CML) Interferon-a Vs. Allogeneic Stem Cell Transplantation Vs. High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase
Study Start Date : July 1997

Primary Outcome Measures :
  1. Survival
  2. Frequency, time-point, and duration of hematologic and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCL-ABL-positive cells
  3. Correlation of quality of hematological and cytogenetic remission with survival time
  4. Course of the terminal phase
  5. Toxicity
  6. Effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time
  7. Effect of early vs late high-dose therapy and autografting on feasibility, toxicity and survival times

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


  • 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



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • No prior interferon


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • Not specified

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): NCT00025402

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Sponsors and Collaborators
III. Medizinische Klinik Mannheim
Study Chair: Ruediger Hehlmann, MD III. Medizinische Klinik Mannheim Identifier: NCT00025402     History of Changes
Other Study ID Numbers: CDR0000068957
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: July 2002

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors