Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia


Phase 2
16 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Intensive Induction for Newly Diagnosed Acute Myelogenous 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Matt E. Kalaycio, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CASE-CCF-4409

NCT ID:

NCT00274807

Start Date:

June 2001

Completion Date:

May 2008

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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