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Depth and durability of response to ibrutinib in CLL: 5-year follow-up of a phase 2 study

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  1. The Number of Signaling Pathways Altered by Driver Mutations in Chronic Lymphocytic Leukemia Impacts Disease Outcome

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  2. Machine learning can identify newly diagnosed patients with CLL at high risk of infection

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  3. Distinct immune composition in lymph node and peripheral blood of CLL patients is reshaped during venetoclax treatment

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  4. Ibrutinib and Venetoclax for First-Line Treatment of CLL

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  5. Blodsygdomme

    Research output: Chapter in Book/Report/Conference proceedingBook chapterCommunication

  • Inhye E Ahn
  • Mohammed Z H Farooqui
  • Xin Tian
  • Janet Valdez
  • Clare Sun
  • Susan Soto
  • Jennifer Lotter
  • Stephanie Housel
  • Maryalice Stetler-Stevenson
  • Constance M Yuan
  • Irina Maric
  • Katherine R Calvo
  • Pia Nierman
  • Thomas E Hughes
  • Nakhle S Saba
  • Gerald E Marti
  • Stefania Pittaluga
  • Sarah E M Herman
  • Carsten U Niemann
  • Lone B Pedersen
  • Christian H Geisler
  • Richard Childs
  • Georg Aue
  • Adrian Wiestner
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The safety and efficacy of ibrutinib (420 mg) in chronic lymphocytic leukemia (CLL) were evaluated in a phase 2 study; 51 patients had TP53 aberration (TP53 cohort) and 35 were enrolled because of age 65 years or older (elderly cohort). Both cohorts included patients with treatment-naive (TN) and relapsed/refractory (RR) CLL. With the median follow-up of 4.8 years, 49 (57.0%) of 86 patients remain on study. Treatment was discontinued for progressive disease in 20 (23.3%) patients and for adverse events in 5 (5.8%). Atrial fibrillation occurred in 18 (20.9%) patients for a rate of 6.4 per 100 patient-years. No serious bleeding occurred. The overall response rate at 6 months, the primary study endpoint, was 95.8% for the TP53 cohort (95% confidence interval, 85.7%-99.5%) and 93.9% for the elderly cohort (95% confidence interval, 79.8%-99.3%). Depth of response improved with time: at best response, 14 (29.2%) of 48 patients in the TP53 cohort and 9 (27.3%) of 33 in the elderly cohort achieved a complete response. Median minimal residual disease (MRD) in peripheral blood was 3.8 × 10-2 at 4 years, with MRD-negative (<10-4) remissions in 5 (10.2%) patients. In the TP53 cohort, the estimated 5-year progression-free survival (PFS) was 74.4% in TN-CLL compared with 19.4% in RR-CLL (P = .0002), and overall survival (OS) was 85.3% vs 53.7%, respectively (P = .023). In the elderly cohort, the estimated 5-year PFS and OS in RR-CLL were 64.8% and 71.6%, respectively, and no event occurred in TN-CLL. Long-term administration of ibrutinib was well tolerated and provided durable disease control for most patients. This trial was registered at www.clinicaltrials.gov as #NCT01500733.

Original languageEnglish
JournalBlood
Volume131
Issue number21
Pages (from-to)2357-2366
Number of pages10
ISSN0006-4971
DOIs
Publication statusPublished - 24 May 2018

ID: 55722903