Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
City of Hope Medical Center
With
National Cancer Institute (NCI)
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.
Age
16–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
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
See Disease Characteristics
Prior hydroxyurea or corticosteroids allowed
At least 48 hours since prior and no concurrent itraconazole or fluconazole
You may not be 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:
More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline
Clareo Health | Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
