N9986: A phase II trial of thalidomide in patients with relapsed chronic lymphocytic leukemia

Neil E. Kay, Tait D. Shanafelt, Timothy G. Call, Wenting Wu, Betsy R. Laplant

Research output: Contribution to journalArticlepeer-review

16 Scopus citations


We enrolled 28 eligible patients with relapsed chronic lymphocytic leukemia (CLL) to a phase II study of single agent thalidomide (200 mg/ d, with dose escalation up to 1000- mg/d over 60 days). The median age was 66 years and 71% were males. Study participants received a median of 2 (range 1-7) prior treatment regimens and 61% had Rai stage 3-4 disease at enrollment. Grade 3 or higher hematologic toxicity was observed in 13 (46%) and 16 (57%) had grade 3 or higher non-hematologic toxicity. Grade 3-4 tumor flare was observed in five (18%) patients. The overall response rate was 11% (3 of 28) with one (4%) complete remission and two (7%) partial remissions. Duration of response for these three responders was 3, 14 and 15 months. Fourteen (50%) patients had stabilisation of disease for a median duration of 8 months (95% CI: 7-16 months). Median time to progression for all 28 patients was 7.3 months. Although thalidomide appears to have modest clinical activity in pretreated/ relapsed CLL primarily based on reduction of the absolute lymphocyte count, in our opinion the toxicity profile precludes it from more active investigation in CLL.

Original languageEnglish (US)
Pages (from-to)588-592
Number of pages5
JournalLeukemia and Lymphoma
Issue number4
StatePublished - 2009


  • Angiogenesis
  • CLL
  • Relapsed
  • Thalidomide
  • Treatment

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research


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