Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: A report from the Eastern Cooperative Oncology Group

Mark R. Litzow, Megan Othus, Larry D. Cripe, Steven D. Gore, Hillard M. Lazarus, Sandra J. Lee, John M. Bennett, Elisabeth M. Paietta, Gordon W. Dewald, Jacob M. Rowe, Martin S. Tallman

Research output: Contribution to journalArticle

48 Scopus citations


The treatment of relapsed acute myeloid leukaemia (AML) remains unsatisfactory. We conducted a phase II randomized trial where patients received intermediate-dose cytarabine for 4 d followed by gemtuzumab ozogamicin on day 5 (Arm A), or combined with liposomal daunorubicin for 3 d (Arm B), or cytarabine given for 5 d combined with cyclophosphamide for 3 d and topotecan by continuous infusion for 5 d (Arm C). Eligible patients had primary refractory AML, a first relapse after a remission of <1 year, or a second or greater relapse. The primary objective of this trial was attainment of a conventional complete remission (CR) or a CR without platelet recovery (CRp) in at least 40% of patients. The CR/CRp rates for the 82 eligible patients were 3/26 (12%) in Arm A, 2/29 (7%) in Arm B, and 1/27 (4%) in Arm C. No patients who had relapsed within 6 months of initial CR or who had suffered multiple relapses responded. More than 95% of patients subsequently died of AML. No unexpected toxicities were encountered. We conclude that none of these three regimens were effective enough in the treatment of high-risk relapsed or refractory AML to warrant further study. This trial was registered at as #NCT00005962.

Original languageEnglish (US)
Pages (from-to)217-225
Number of pages9
JournalBritish journal of haematology
Issue number2
StatePublished - Jan 1 2010



  • Acute myeloid leukaemia
  • Gemtuzumab ozogamicin
  • Liposomal daunorubicin
  • Relapse
  • Topotecan

ASJC Scopus subject areas

  • Hematology

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