Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274807

Enrollment

Registered

2006-01-11

Start date

2001-06-30

Completion date

2008-05-31

Last updated

2011-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

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)

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.

Detailed description

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.

Interventions

BIOLOGICALfilgrastim

DRUGcytarabine

DRUGetoposide

DRUGmitoxantrone hydrochloride

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026