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OpenTrials
Completed

NCT Number: NCT00274807

Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Cytarabine

Drug

etoposide

Drug

mitoxantrone hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia

Important dates

Study start
2001
Primary completion
2007
Study completion
2008
First posted
Jan 11, 2006
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.