Phase II trial of subcutaneous recombinant human interleukin 11 with subcutaneous recombinant human granulocyte-macrophage colony stimulating factor in patients with acute myeloid leukemia (AML) receiving high-dose cytarabine during induction: ECOG 3997

Larry D. Cripe, Kevin Rader, Martin S. Tallman, Michael S. Gordon, Elisabeth Paietta, John Bennett, Donna Neuberg, Mark R. Litzow, Timothy E. O'Brien, Jacob M. Rowe

Research output: Contribution to journalArticle

5 Scopus citations


Randomized trials of substituting high-dose cytarabine (HiDAC) for standard dose cytarabine (SDAC) during induction therapy for newly diagnosed AML have not demonstrated an improvement in the complete remission (CR) rate. Phase II trials of the scheduled administration of HiDAC after SDAC suggest an improved outcome. The hematological complications of intensification are considerable. GM-CSF after chemotherapy improved the survival of older patients in a randomized trial. Recombinant human interleukin 11, a thrombopoietic cytokine, reduced the incidence of chemotherapy-induced thrombocytopenia in patients with solid tumors. Therefore, 34 patients were treated, with newly diagnosed AML less than 56 years of age, with daunorubicin 45 mg/m2 on days 1-3, cytarabine 100 mg/m2 days 1-7 and cytarabine 2 g/m2 for 12 h on days 8-10 (7 + 3 + 3). rhIL-11 (50 μg/kg/day,) and GM-CSF (250 μg/kg/day) were administered subcutaneously from day 11 until recovery. The complete remission rate was 59% (90% C.I. 43-73%). The median time to recovery of neutrophils to >500 and platelets to ≥20,000 μl-1 was 27 days (95% C.I. 27-30 days) and 25 days (95% C.I. 24-29 days), respectively. The trial does not confirm the high CR rate observed in phase II trials, despite optimal supportive care.

Original languageEnglish (US)
Pages (from-to)823-827
Number of pages5
JournalLeukemia Research
Issue number7
StatePublished - Jul 1 2006
Externally publishedYes



  • Acute myeloid leukemia
  • High-dose cytarabine
  • Induction chemotherapy
  • Recombinant interleukin 11
  • Thrombocytopenia

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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