Cladribine prolongs progression-free survival and time to second treatment compared to fludarabine and high-dose chlorambucil in chronic lymphocytic

Research output: Contribution to journalArticle


We conducted a randomized phase III trial to compare the efficacy and safety of two purine analogs, cladribine and fludarabine, with high-dose chlorambucil, in patients with previously untreated chronic lymphocytic leukemia (CLL). Between 1997 and 2004, 223 patients with CLL were randomly assigned to cladribine, fludarabine or chlorambucil, for six cycles of therapy with frequent health-related quality of life assessments. There was no statistical difference for the primary endpoint of overall response with cladribine (70%), fludarabine (67%) and chlorambucil (59%), or complete remission (12%, 7% and 8%), respectively. However, the median progression-free survival (25, 10, 9 months) and median time to second treatment (40, 22, 21 months) were superior with cladribine. There was no significant difference in overall survival (96, 82 and 91 months), nor in toxicity or HRQoL assessments. Monotherapy with cladribine gives superior PFS and longer response duration than fludarabine and chlorambucil as first-line treatment of CLL.


  • Stephen P. Mulligan
  • Karin Karlsson
  • Mats Stromberg
  • Viggo Jonsson
  • Devinder Gill
  • Jens Hammerstrom
  • Mark Hertzberg
  • Roger McLennan
  • Bertil Uggla
  • John Norman
  • Jonas Wallvik
  • Gunnel Sundstrom
  • Hemming Johansson
  • Yvonne Brandberg
  • Jan Liliemark
  • Gunnar Juliusson
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology


  • Lymphoid leukemia, chemotherapeutic approaches, pharmacotherapeutics, CLL
Original languageEnglish
Pages (from-to)2769-2777
JournalLeukemia & Lymphoma
Issue number12
Publication statusPublished - 2014
Publication categoryResearch

Bibliographic note

The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Hematology/Transplantation (013022014)