Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004128
First received: December 10, 1999
Last updated: December 22, 2009
Last verified: April 2008
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Duration of overall survival and disease-free survival after first randomization [ Designated as safety issue: No ]
  • Duration of overall survival and disease-free survival after second randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response after induction and consolidation [ Designated as safety issue: No ]
  • Toxicity measured by Cancer and Leukemia Group B (CALGB) CTCAE v3.0 after induction and consolidation [ Designated as safety issue: Yes ]
  • Disease-free survival after complete remission (CR) [ Designated as safety issue: No ]
  • Disease-free interval from CR [ Designated as safety issue: No ]
  • Time to death in CR [ Designated as safety issue: No ]
  • Peripheral stem cell harvest after consolidation [ Designated as safety issue: No ]
  • Rate of completion of autologous peripheral blood stem cell transplantation (auto-PBSCT) and allogeneic stem cell transplantation (allo-SCT) [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: September 1999
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 15 to 60

Performance status:

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

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

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

Renal:

  • Creatinine no greater than 3 times ULN

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

  • No prior radiotherapy for AML

Surgery:

  • Not specified
  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: NCT00004128

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

Additional Information:
Publications:
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00004128     History of Changes
Other Study ID Numbers: CDR0000067356, EORTC-06991, GIMEMA-EORTC-06991
Study First Received: December 10, 1999
Last Updated: December 22, 2009
Health Authority: United States: Federal Government

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:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Daunorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014