Interferon-alpha 2b (IFN alpha) for early-phase chronic lymphocytic leukaemia with high risk for disease progression: results of a randomized multicentre study

Br J Haematol. 1996 Aug;94(2):362-9. doi: 10.1046/j.1365-2141.1996.d01-1796.x.


The efficacy of interferon-alpha 2b (IFN alpha) to prolong progression-free (PFS) and/or overall survival (OS) in early B-CLL (Binet stage A) was examined in a risk-adapted phase III study. 99 previously untreated B-CLL patients were recruited. 44 patients with expected high risk for disease progression, defined by non-nodular bone marrow infiltration and lymphocyte doubling time < or = 12 months or serum thymidine kinase levels > or = 5 U/I, were randomized to either receive IFN alpha (group 1, n = 21) or not (group 2, n = 23). 55 low-risk patients were observed to evaluate this risk stratification (group 3). During a median observation time of 36 months, four patients in the IFN alpha group achieved a partial remission (PR), no patient had stable disease (SD), and 17 patients experienced progressive disease (PD). The four responders had less extensive disease at study entry and tended to exhibit a rise in serum IgG levels. In group 2, no PR, seven SD and 16 PD, whereas in group 3, no PR, 37 SD and 18 PD occurred. PFS in group 1 (6.7 months) was not different from group 2 (13.3 months, P = 0.22), but PFS of groups 1 and 2 differed from group 3 (37 months, P < or = 0.001). OS was 44.9 months (group 1), 43.1 months (group 2) and 57.9 months (group 3). OS was not significantly different for group 1 v 2, but was significant between groups 1 and 3 (P = 0.023). The higher percentage of PD in group 2 compared to group 3 (70% v 29%) shows that the selected risk factors allow the definition of CLL stage A patients at risk for disease progression within about a year. In conclusion, our data indicate that IFN alpha does not prolong PFS or OS in stage A CLL patients with high risk for disease progression.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Disease Progression
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Forecasting
  • Humans
  • Immunoglobulin A / metabolism
  • Immunoglobulin G / metabolism
  • Immunoglobulin M / metabolism
  • Interferon alpha-2
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use*
  • Leukemia, Lymphocytic, Chronic, B-Cell / therapy*
  • Male
  • Middle Aged
  • Recombinant Proteins
  • Risk Factors


  • Immunoglobulin A
  • Immunoglobulin G
  • Immunoglobulin M
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins