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

Leuk Res. 2003 Oct;27(10):887-91. doi: 10.1016/s0145-2126(03)00021-3.

Abstract

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.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aminoglycosides*
  • Anti-Bacterial Agents / administration & dosage
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / toxicity*
  • Cyclosporine / administration & dosage
  • Cytarabine / administration & dosage
  • Daunorubicin / administration & dosage
  • Female
  • Gemtuzumab
  • Humans
  • Leukemia, Myeloid, Acute / complications
  • Leukemia, Myeloid, Acute / drug therapy*
  • Liposomes / therapeutic use
  • Male
  • Middle Aged
  • Pilot Projects
  • Remission Induction
  • Salvage Therapy
  • Treatment Outcome

Substances

  • Aminoglycosides
  • Anti-Bacterial Agents
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Liposomes
  • Cytarabine
  • Cyclosporine
  • Gemtuzumab
  • Daunorubicin