Overview

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

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cytarabine
Idarubicin
Criteria
DISEASE CHARACTERISTICS:

Inclusion criteria:

- 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

Exclusion criteria:

- 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