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Context: Ibrutinib, a first-in-class, once-daily oral, covalent inhibitor of Bruton's tyrosine kinase, demonstrated single-agent activity and an acceptable safety profile in a phase II relapsed/refractory (R/R) CLL/SLL study (Byrd et al. NEJM 2013). Ibrutinib is FDA approved for CLL patients who have received ≥1 prior therapy, and for patients with del(17p)(More)
(4217 articles) Neoplasia (3667 articles) Clinical Trials and Observations Articles on similar topics can be found in the following Blood collections Information about subscriptions and ASH membership may be found online at: digital object identifier (DOIs) and date of initial publication. the indexed by PubMed from initial publication. Citations to Advance(More)
Key Points • Three-year follow-up of ibrutinib in CLL demonstrated continued activity with durable responses that improve in quality with extended treatment. • Toxicity diminished over time with respect to grade $3 cytopenias, fatigue, infections, and adverse events leading to discontinuation. Ibrutinib is an orally administered inhibitor of Bruton tyrosine(More)
Approximately 1,000 microRNAs (miRs) are present in the human genome; however, little is known about the regulation of miR transcription. Because miR levels are deregulated in chronic lymphocytic leukemia (CLL) and signal transducer and activator of transcription (STAT)-3 is constitutively activated in CLL, we sought to determine whether STAT3 affects the(More)
Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor approved for the treatment of several types of blood cancer. Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box warning for fatal and/or severe(More)
Comparison of idarubicin ϩ ara-C–, fludarabine ϩ ara-C–, and topotecan ϩ ara-C–based regimens in treatment of newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts in transformation, or refractory anemia with excess blasts It has been unclear whether regimens containing topotecan ؉ ara-C (TA) or flu-darabine ؉ ara-C (FA) ؎ idarubicin(More)
CLL cell trafficking between blood and tissue compartments is an integral part of the disease process. Idelalisib, a phosphoinositide 3-kinase delta (PI3Kδ) inhibitor causes rapid lymph node shrinkage, along with an increase in lymphocytosis, prior to inducing objective responses in CLL patients. This characteristic activity presumably is due to CLL cell(More)
PURPOSE To assess ibrutinib pharmacokinetics under fasted and fed conditions, impact of food-intake timing, and the safety and tolerability. METHODS Three studies were analyzed. Study 1 was a randomized, open-label, single-dose, four-way crossover study in 44 healthy participants. Study 2 was a randomized, repeat-dose crossover study in 16 patients with(More)
BACKGROUND Previous studies have suggested that NPM1 mutations may be a marker for response to all-trans retinoic acid (ATRA) given as an adjunct to intensive chemotherapy in older patients with acute myeloid leukemia (AML). PATIENTS AND METHODS We examined the impact of the addition of ATRA among patients with diploid cytogenetics treated on a randomized(More)
Acknowledgments: the authors would like to thank Sherry Pierce for her critical review of the manuscript. Funding: this work was supported by grant funding provided through NIH grant P-01 CA049639. Background Outcomes in chronic myeloid leukemia have improved with tyrosine kinase inhibitor treatment. However, little is known about outcomes of chronic(More)