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Blood, 1 June 2008, Vol. 111, No. 11, pp. 5291-5297.
Prepublished online as a Blood First Edition Paper on March 11, 2008; DOI 10.1182/blood-2007-12-130120.
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CLINICAL TRIALS AND OBSERVATIONS
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia
Alessandra Ferrajoli1,
Bang-Ning Lee2,
Ellen J. Schlette3,
Susan M. O'Brien1,
Hui Gao2,
Sijin Wen4,
William G. Wierda1,
Zeev Estrov1,
Stefan Faderl1,
Evan N. Cohen2,
Changping Li2,
James M. Reuben2, and
Michael J. Keating1
Departments of 1 Leukemia
2 Hematopathology Research
3 Hematopathology, and
4 Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston
This study investigated the activity of lenalidomide in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Lenalidomide was given at 10 mg daily with dose escalation up to 25 mg daily. Three patients (7%) achieved a complete response (CR), one a nodular partial remission, and 10 patients a partial remission (PR), for an overall response (OR) rate of 32%. Treatment with lenalidomide was associated with an OR rate of 31% in patients with 11q or 17p deletion, of 24% in patients with unmutated VH, and of 25% in patients with fludarabine-refractory disease. The most common toxicity was myelosuppression, and the median daily dose of lenalidomide tolerated was 10 mg. Plasma levels of angiogenic factors, inflammatory cytokines, and cytokine receptors were measured at baseline, day 7, and day 28. There was a dramatic increase in median interleukin (IL)-6, IL-10, IL-2, and tumor necrosis factor receptor-1 levels on day 7, whereas no changes were observed in median vascular endothelial growth factor levels (20 patients studied). According to our experience, lenalidomide given as a continuous treatment has antitumor activity in heavily pretreated patients with CLL. This trial is registered at http://www.clinicaltrials.gov as no. NCT00267059
[ClinicalTrials.gov]
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