Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Leukemia

In brief

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, 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 giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Key facts

Study ID

NCT00528398

Run by

City of Hope Medical Center

People needed

111

Starts

1994-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-02-06

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed acute myeloid leukemia (AML)
• Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
• FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
• Previously untreated with radiotherapy or chemotherapy
• Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
• Patients with prior myelodysplastic syndrome are eligible
• Extramedullary leukemia allowed
• AML with lymphoid markers allowed

You may not qualify if…

• Blastic transformation of chronic myelogenous leukemia
• Biphenotypic leukemia
• FAB M3 disease (acute promyelocytic leukemia)
• PATIENT CHARACTERISTICS:
• Life expectancy ≥ 6 weeks
• Total bilirubin < 1.5 g/dL
• AST and ALT < 5 times upper limit of normal (ULN)
• Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min
• Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
• HIV antibody-negative
• PRIOR CONCURRENT THERAPY:
• Inclusion criteria:
• See Disease Characteristics
• Prior hydroxyurea or corticosteroids allowed
• At least 48 hours since prior and no concurrent itraconazole or fluconazole
• Exclusion criteria:
• More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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