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Xavier Badoux, William Wierda, Susan O'Brien, Stefan Faderl, Steven Kornblau,

A Phase II Study of Lenalidomide as Initial Treatment of Elderly Patients with Chronic Lymphocytic Leukemia. Xavier Badoux, William Wierda, Susan O'Brien, Stefan Faderl, Steven Kornblau, Kimberly Yerrow, Zeev Estrov, Hagop Kantarjian, Michael Keating and Alessandra Ferrajoli.

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Xavier Badoux, William Wierda, Susan O'Brien, Stefan Faderl, Steven Kornblau,

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  1. A Phase II Study of Lenalidomide as Initial Treatment of Elderly Patients with Chronic Lymphocytic Leukemia Xavier Badoux, William Wierda, Susan O'Brien, Stefan Faderl, Steven Kornblau, Kimberly Yerrow, Zeev Estrov, Hagop Kantarjian, Michael Keating and Alessandra Ferrajoli

  2. DisclosuresXavier Badoux, MB BS Presentation includes discussion of off-label use of lenalidomide in CLL.

  3. Lenalidomide in Elderly CLL: Introduction • Median age at diagnosis of CLL: 72 years • Elderly patients with CLL • Under-represented in clinical trials • Increased toxicity with chemoimmunotherapy • Lenalidomide • Immunomodulatory drug • Oral administration • Active in relapsed CLL SEER Cancer Statistics Review, NCI (2009); Eichhorst B, Leuk & Lymph (2009); Chanan-Khan A et al. JCO (2006); Ferrajoli A et al. Blood (2008).

  4. Lenalidomide in Elderly CLL: Study Design • Phase II, 60 patients • Untreated and symptomatic (NCI-WG) • Age ≥ 65 yrs • Creatinine <2 mg/dL, bilirubin<2 mg/dL • Performance status 0-2 • Response assessed at end of Cycle 3, then every 6 cycles (2008 NCI-WG) ClinicalTrials.gov (ID# NCT00535873)

  5. Lenalidomide in Elderly CLL: Treatment Schedule • Lenalidomide • 5 mg orally daily x 2 cycles (56 days) • Increase by 5 mg/cycle (28 days) to maximum 25 mg daily • Treatment continued until progression • Allopurinol 300 mg d1-14 • No mandated antibiotic, anti-viral, DVT or tumor flare prophylaxis

  6. Lenalidomide in Elderly CLL: Study Endpoints • Efficacy: 1. Progression-free survival 2. Clinical Responses (2008 NCI-WG) • Toxicity: Grade 3-4 non-hematological • Correlative Studies:Lymphocyte subsets analysis: blood and marrow Serum immunoglobulin levels

  7. Lenalidomide in Elderly CLL: Patient Pre-treatment Characteristics Not evaluable: *IgVH: n=5, **CD38: n=1

  8. Lenalidomide in Elderly CLL: Response (2008 NCI-WG Criteria) *4 patients with flow cytometry negative CR

  9. Lenalidomide in Elderly CLL: Responses at Assessment Times

  10. Lenalidomide in Elderly CLL: Responses by Pre-treatment Characteristics *p<0.05

  11. Lenalidomide in Elderly CLL: Overall and Progression-free Survival Median follow-up 23 months: OS = 90% PFS = 60%

  12. Lenalidomide in Elderly CLL: Normalization of PB Lymphocytes (n=38) *p<0.001

  13. Lenalidomide in Elderly CLL: Reconstitution of BM Lymphocytes (n=38) (%) *p<0.001,**p<0.01

  14. Lenalidomide in Elderly CLL: Improvement in Serum Igs (n=37) *p<0.001 Cycles of therapy Cycles of therapy 8 / 16 (50%) patients with IgG<600mg/dl → normalized serum IgG

  15. Lenalidomide in Elderly CLL: Hematological Toxicity *NCI-working group criteria

  16. Lenalidomide in Elderly CLL: Infections

  17. Lenalidomide in Elderly CLL: Other Toxicities

  18. Lenalidomide in Elderly CLL: Conclusions • Lenalidomide as frontline therapy in elderly CLL • Estimated 2-year OS 90%;2-year PFS 60% • ORR 62 %; CR/CRi15% • Quality of response improves with time • Myelosuppression most common toxicity • No severe tumor flare or tumor lysis syndrome • ↑ serum Ig levels • Normalization of lymphocyte populations

  19. Thank you

  20. Lenalidomide in Elderly CLL: Clinical Responses by Dose Intensity *p<0.01, **p<0.001

  21. Lenalidomide in Elderly CLL: Best Clinical Response: 2008 NCI-WG

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