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Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00274807
First received: January 10, 2006
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
January 10, 2006
February 9, 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 ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2008
April 2007   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00274807
CASE-CCF-4409
P30CA043703 ( US NIH Grant/Contract Award Number )
CASE-CCF-4409
CASE-CCF-0645
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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