A multicenter, open, noncomparative, phase II study of the combination of cladribine (2-chlorodeoxyadenosine), cytarabine, granulocyte colony-stimulating factor and mitoxantrone as induction therapy in refractory acute myeloid leukemia: a report of the Polish Adult Leukemia Group

Ann Hematol. 2005 Sep;84(9):557-64. doi: 10.1007/s00277-005-1046-0. Epub 2005 Apr 27.

Abstract

Purine nucleoside analogues, cladribine (2-chlorodeoxyadenosine, 2-CdA) and fludarabine (FAMP) are active agents in acute myeloid leukemias (AMLs). Synergistic interaction between FAMP or 2-CdA with cytarabine (cytosine arabinoside, Ara-C) has been demonstrated in preclinical and clinical studies. The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of induction treatment consisting of 2-CdA (5 mg/m2), Ara-C (2 g/m2), mitoxantrone (MIT, 10 mg/m2) and granulocyte colony-stimulating factor (G-CSF) (CLAG-M) in refractory AML. In case of partial remission, a second CLAG-M was administered. Patients in complete remission (CR) received consolidation courses based on high-dose Ara-C and MIT with or without 2-CdA. Forty-three patients from five centers were registered: 25 primary resistant and 18 relapsed. CR was achieved in 21 (49%) patients, 20 (47%) were refractory and 2 (5%) died early. Hematologic toxicity was the most prominent toxicity of this regimen. The overall survival (OS; 1 year) for the 42 patients as a whole and the 20 patients in CR were 43% and 73%, respectively. Disease-free survival (1 year) was 68.6%. None of the analyzed prognostic factors influenced the CR and OS probability significantly. We conclude that CLAG-M regimen has significant antileukemia activity in refractory AML, which seems to be better than the activity of many other regimens. The toxicity of the treatment is acceptable.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / toxicity
  • Cladribine / administration & dosage
  • Cytarabine / administration & dosage
  • Drug Therapy, Combination
  • Female
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Hematologic Diseases / chemically induced
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Leukemia, Myeloid / drug therapy*
  • Leukemia, Myeloid / mortality
  • Male
  • Middle Aged
  • Mitoxantrone / administration & dosage
  • Remission Induction / methods
  • Salvage Therapy / methods
  • Survival Analysis

Substances

  • Cytarabine
  • Granulocyte Colony-Stimulating Factor
  • Cladribine
  • Mitoxantrone

Supplementary concepts

  • CLAG protocol