Gemtuzumab ozogamicin, fludarabine, cytarabine and cyclosporine combination regimen in patients with CD33+ primary resistant or relapsed acute myeloid leukemia

Apostolia Tsimberidou, Jorge Cortes, Deborah Thomas, Guillermo Garcia-Manero, Srdan Verstovsek, Stephan Faderl, Maher Albitar, Hagop Kantarjian, Elihu Estey, Francis J. Giles

Research output: Contribution to a Journal (Peer & Non Peer)Articlepeer-review

68 Citations (Scopus)

Abstract

Clinical resistance to gemtuzumab ozogamicin (Mylotarg™) in acute myeloid leukemia (AML) is associated with blast multidrug resistance (MDR) phenotype. A Phase II study of Mylotarg, fludarabine, ara-C and the MDR-modifier, cyclosporine (CSA) (MFAC) was conducted in 32 patients with primary resistant (11, 34%) or relapsed (21, 66%) AML. Nine (28%) patients obtained complete remission (CR), two (6%) CR with incomplete platelet recovery. Overall median survival was 5.3 months, 12-month survival rate 19%. Fourteen patients (44%) developed grade 3/4 hyperbilirubinemia; six (18%) grade 3/4 hepatic transaminitis; three (9%) hepatic veno-occlusive disease (VOD). CSA inclusion in gemtuzumab ozogamicin-based regimens is feasible. MFAC is an effective regimen for refractory AML.

Original languageEnglish
Pages (from-to)893-897
Number of pages5
JournalLeukemia Research
Volume27
Issue number10
DOIs
Publication statusPublished - 1 Oct 2003
Externally publishedYes

Keywords

  • Acute myelogenous leukemia
  • Cyclosporine
  • Cytarabine
  • Fludarabine
  • Gemtuzumab ozogamicin
  • Mylotarg™
  • Refractory

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