Pilot study of gemtuzumab ozogamicin, liposomal daunorubicin, cytarabine and cyclosporine regimen in patients with refractory acute myelogenous leukemia

Efrosyni Apostolidou, Jorge Cortes, Apostolia Tsimberidou, Elihu Estey, Hagop Kantarjian, Francis J. Giles

Research output: Contribution to journalArticle

53 Scopus citations


Multi-drug resistance (MDR) protein expression is associated with reduced gemtuzumab ozogamicin (Mylotarg) activity. Both cyclosporine-A (CSA) and liposome-encapsulated daunorubicin, DaunoXome (DNX) may reduce the negative impact of MDR. A gemtuzumab ozogamicin, DNX, cytarabine (ara-C) and CSA (MDAC) regimen was piloted in patients with refractory acute myelogenous leukemia (AML) (relapsed 10, primary refractory 1) (median age 37 years (16-67)). One (9%) patient achieved a transient CR, one CRp. Grade 3/4 toxicities included sepsis (seven patients; 63%); hyperbilirubinemia (six patients; 54%), with transaminitis in one patient; mucositis (three patients; 27%). The inclusion of CSA in a gemtuzumab ozogamicin-containing regimen is feasible. The MDAC regimen was associated with significant toxicity in a cohort of patients with very advanced AML.

Original languageEnglish (US)
Pages (from-to)887-891
Number of pages5
JournalLeukemia Research
Issue number10
StatePublished - Oct 1 2003
Externally publishedYes



  • Acute myeloid leukemia
  • Cyclosporine-A
  • Cytarabine
  • DaunoXome
  • Gemtuzumab ozogamicin
  • MDR
  • Multi-drug resistance
  • Refractory

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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