Combination Chemotherapy in Treating Patients With Newly Diagnosed 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: NCT00274807
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : February 11, 2011
National Cancer Institute (NCI)
Information provided by:
The Cleveland Clinic

January 10, 2006
January 11, 2006
February 11, 2011
June 2001
April 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00274807 on Archive Site
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Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.


  • Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide.
  • Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia.

OUTLINE: Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3, cytarabine IV continuously over 72 hours on days 1-3 and 8-10, and etoposide IV continuously over 72 hours on days 8-10. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 4 and continuing until blood counts recover.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Biological: filgrastim
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: mitoxantrone hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2008
April 2007   (Final data collection date for primary outcome measure)


  • Diagnosis of acute myeloid leukemia

    • Previously untreated disease

      • Previous hydroxyurea and/or corticosteroids are acceptable
  • No preexisting history of a hematologic disorder

    • Myelodysplastic features allowed
  • No acute leukemia secondary to previous therapy
  • No leukemic meningitis


  • Bilirubin < 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia)
  • Creatinine < 2.0 mg/dL
  • Pregnant or lactating patients are ineligible
  • Fertile patients must use effective contraception
  • No history of or active congestive heart failure


  • See Disease Characteristics
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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P30CA043703 ( U.S. NIH Grant/Contract )
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Matt Kalaycio, Cleveland Clinic Foundation
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: Matt E. Kalaycio, MD The Cleveland Clinic
The Cleveland Clinic
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP