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Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid 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: NCT00004128
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 23, 2009
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy or radiation therapy is given prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Interleukin-2 may stimulate the patient's white blood cells to kill cancer cells.

PURPOSE: This randomized phase III trial is studying two different regimens of combination chemotherapy, interleukin-2, and peripheral stem cell transplant and comparing them to see how well they work in treating patients with acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: aldesleukin Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Procedure: autologous 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 : 2000 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: The Value of High Dose Versus Standard Dose ARA-C During Induction and of IL-2 After Intensive Consolidation/Autologous Stem Cell Transplantation in Patients (Age 15-60 Years) With Acute Myelogenous Leukemia. A Randomized Phase II Trial of the EORTC and the GIMEMA-ALWP
Study Start Date : September 1999
Estimated Primary Completion Date : January 2008

Primary Outcome Measures :
  1. Duration of overall survival and disease-free survival after first randomization
  2. Duration of overall survival and disease-free survival after second randomization

Secondary Outcome Measures :
  1. Response after induction and consolidation
  2. Toxicity measured by Cancer and Leukemia Group B (CALGB) CTCAE v3.0 after induction and consolidation
  3. Disease-free survival after complete remission (CR)
  4. Disease-free interval from CR
  5. Time to death in CR
  6. Peripheral stem cell harvest after consolidation
  7. Rate of completion of autologous peripheral blood stem cell transplantation (auto-PBSCT) and allogeneic stem cell transplantation (allo-SCT)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • First randomization:

    • Untreated newly diagnosed acute myeloid leukemia (AML)
    • At least 30% blasts in bone marrow
    • All cytological types of AML except acute promyelocytic leukemia (M3)
    • No blast crisis of chronic myelogenous leukemia
    • No leukemias supervening after other myeloproliferative disease
    • No leukemias supervening after overt myelodysplastic disorders (e.g., refractory anemia with excess blasts) for more than 6 months duration
  • Second randomization:

    • Must have achieved complete remission with full hematologic recovery following consolidation treatment
    • No HLA identical family donor
    • Not eligible for allograft
    • No high risk patient (under age 40) for whom an unrelated bone marrow donor has been found within 8 weeks of beginning consolidation treatment



  • 15 to 60

Performance status:

  • WHO 0-3 (first randomization)
  • WHO 0-2 (second randomization)

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 3 times upper limit of normal (ULN)


  • Creatinine no greater than 3 times ULN


  • No severe heart failure requiring diuretics
  • Ejection fraction at least 50%


  • First randomization:

    • No other progressive malignant disease except the following:

      • Secondary acute leukemias following curatively treated Hodgkin's disease (even if treated with anthracyclines)
      • Other curatively treated malignancies
      • Secondary leukemias following other exposure to alkylating agents or radiotherapy for other reason
    • No uncontrolled infection
    • No severe concurrent neurologic or psychiatric disease
    • No psychological, familial, sociological, or geographical condition that could preclude compliance
  • Second randomization:

    • No nonmalignant systemic illness that would increase risk of participation in study
    • No uncontrolled infection
    • No other progressive malignant disease


Biologic therapy:

  • Not specified


  • No prior chemotherapy for AML except hydroxyurea
  • Less than 7 days of prior hydroxyurea

Endocrine therapy:

  • No more than 7 days of prior corticosteroid therapy for AML


  • No prior radiotherapy for AML


  • 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): NCT00004128

Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Gruppo Italiano Malattie EMatologiche dell'Adulto
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OverallOfficial: Roel Willemze, MD, PhD Leiden University Medical Center
Study Chair: Giovanna Meloni, MD University La Sapienza

Publications of Results:
Aslanyan MG, Langemeijer SMC, Cilloni D, et al.: Incidence and clinical impact of TET2 mutations in acute myeloid leukemia patients treated within the EORTC/GIMEMA AML-12/06991 AML trial. [Abstract] Blood 114 (22): A-2609, 2009.
Willemze R, Suciu S, Mandelli F, et al.: Value of low dose IL-2 as maintenance following consolidation treatment or autologous transplantation in acute myelogenous leukemia (AML) patients aged 15-60 years who reached CR after high dose (HD-AraC) vs standard dose (SD-AraC) cytosine arabinoside during induction: results of the AML-12 trial of EORTC and GIMEMA Leukemia Groups. [Abstract] Blood 114 (22): A-791, 2009.

Other Publications:
Maurillo L, Buccisano F, Spagnoli A, et al.: In acute myeloid leukemia, the use in induction of standard dose arac is associated with a better quality of response as compared to an induction regimen containing high dose arac. [Abstract] Blood 114 (22): A-1584, 2009.

Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00004128    
Other Study ID Numbers: CDR0000067356
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: April 2008
Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute megakaryoblastic leukemia (M7)
adult acute monocytic leukemia (M5b)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Anti-HIV Agents
Anti-Retroviral Agents