Phase 2
Completed N=111
Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
Source: ClinicalTrials.gov NCT00528398 ↗Enrolled (actual)
111
Serious AEs
46.0%
Results posted
Feb 2017
Primary outcomePrimary: Complete Remission (CR) — 77; 32; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission (CR) |
77; 32; 2 | — |
| SECONDARY Bone Marrow at Day 7 Post-Induction Chemotherapy |
17; 90; 4 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00528398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.