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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Drug: cytarabine Drug: etoposide Drug: mitoxantrone hydrochloride Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia
Study Start Date : June 2001
Actual Primary Completion Date : April 2007
Actual Study Completion Date : May 2008

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

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): NCT00274807

Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: Matt E. Kalaycio, MD The Cleveland Clinic

Responsible Party: Matt Kalaycio, Cleveland Clinic Foundation Identifier: NCT00274807     History of Changes
Other Study ID Numbers: CASE-CCF-4409
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011

Keywords provided by The Cleveland Clinic:
untreated adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
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, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents