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

City of Hope

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: idarubicin; Drug: cytarabine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00528398

CDR0000564537 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

93139

CHNMC-93139-94-03-1

CHNMC-93139

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the complete remission rate (CR).
• Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
• Further evaluate the toxicity of this regimen.

OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Enrollment: 111 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

Treatment (idarubicin, cytarabine)

Experimental group

Description:

Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Treatment:

Drug: cytarabine

Drug: idarubicin