Phase II study of aclarubicin in acute myeloblastic leukemia

Am J Clin Oncol. 1987 Dec;10(6):523-6. doi: 10.1097/00000421-198712000-00014.


Aclarubicin is a new anthracycline antibiotic that produces substantially less cardiotoxicity in animals that does doxorubicin. Based upon prior Phase I and II trials in leukemia, a Phase II study in acute myeloblastic leukemia was developed to assess the response rate and toxicity in previously treated patients. Forty patients received aclarubicin 100 mg/m2 per day X 3 with repeated course on days 14-16 if marrow hypoplasia was not produced. Complete responses were achieved in 27.5% (11/40) with durations of 1.5, 2, 2, 2, 3, 3+, 4, 5+, 32+, 33+, and 34+ months. Toxic effects of this therapy included severe neutropenia and thrombocytopenia, nausea/vomiting, mucositis, and diarrhea. No patient developed significant changes in the left ventricular ejection fraction, as measured by radionuclide angiography, or any clinical cardiac symptoms. Alopecia was minimal. Aclarubicin can produce a significant response rate in previously treated patients with acute myeloblastic leukemia and should be considered for study in initial therapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aclarubicin
  • Adolescent
  • Adult
  • Aged
  • Antibiotics, Antineoplastic / therapeutic use*
  • Drug Evaluation
  • Electrocardiography
  • Heart / drug effects
  • Humans
  • Leukemia, Myeloid, Acute / drug therapy*
  • Middle Aged
  • Naphthacenes / adverse effects
  • Naphthacenes / therapeutic use


  • Antibiotics, Antineoplastic
  • Naphthacenes
  • Aclarubicin