Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukemia

Yesid Alvarado, Apostolia Tsimberidou, Hagop Kantarjian, Jorge Cortes, Guillermo Garcia-Manero, Stefan Faderl, Deborah Thomas, Elihu Estey, Francis J. Giles

Research output: Contribution to journalArticle

63 Scopus citations


Purpose: Mylotarg has moderate activity as a single agent in patients with CD33-positive refractory or relapsed acute myelogenous leukemia (AML). A combination of an anthracycline and cytarabine (ara-C) is the core of most AML induction regimens. We conducted a pilot study of Mylotarg combined with idarubicin and ara-C in patients with refractory or relapsed AML. Methods: Mylotarg was administered at 6 mg/m2 intravenously on days 1 and 15, idarubicin 12 mg/m2 daily on days 2 through 4, and ara-C at 1.5 g/m2 daily on days 2 through 5 (MIA). Results: Of 14 patients were treated, 4 (29%) had primary resistant AML, and 10 (71%) relapsed AML. The median age of the patients was 61 years (range 34-74 years). MIA induced complete remission (CR) in three patients (21%) and CR with incomplete platelet recovery (CRp) in three patients (21%). The median survival was 8 weeks (range 2-64 weeks), and the median failure-free survival of CR patients was 27 weeks (range 11-64 weeks). All patients developed grade 3/4 myelosuppression - severe sepsis occurred in ten patients (71%). Other grade 3/4 nonhematologic toxicities included hepatic transaminitis, oral mucositis, and diarrhea. Two patients (14%) developed hepatic venoocclusive disease (VOD). Conclusions: The addition of Mylotarg to idarubicin and ara-C is feasible. MIA has significant activity in patients with refractory AML. Hepatotoxicity and VOD are significant toxicities of Mylotarg-based combinations.

Original languageEnglish (US)
Pages (from-to)87-90
Number of pages4
JournalCancer Chemotherapy and Pharmacology
Issue number1
Publication statusPublished - Jan 16 2003
Externally publishedYes



  • Acute myeloid leukemia
  • Cytarabine
  • Idarubicin
  • Mylotarg
  • Venoocclusive disease

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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