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Efficacy results of a phase 2 trial of first-line idelalisib plus ofatumumab in chronic lymphocytic leukemia

Benjamin L. Lampson, Haesook T. Kim, Matthew S. Davids, Jeremy S. Abramson, Arnold S. Freedman, Caron A. Jacobson, Philippe A. Armand, Robin M. Joyce, Jon E. Arnason, Laura Z. Rassenti, Thomas J. Kipps, Joshua Fein, Stacey M. Fernandes, John R. Hanna, David C. Fisher and Jennifer R. Brown

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Tables

  • Table 1.

    Patient demographics and baseline clinical characteristics

    Characteristicn%
    Total number of patients27
    Median age (range), y69 (57-84)
    Sex
     Male2177.8
     Female622.2
    ECOG performance status
     02385.2
     1414.8
    Diagnosis
     CLL23*85.2
     SLL414.8
    Rai stage at therapy initiation
     1311.1
     2518.5
     3414.8
     41555.6
    Cytogenetics (Döhner hierarchy)
     17p deletion311.1
     11q deletion311.1
     Trisomy 12725.9
     13q deletion829.6
     Normal622.2
    IGHV status
     Mutated >2%1451.8
     Unmutated1348.1
    ZAP-70 status
     Negative933.3
     Positive1451.9
     Not recorded414.8
    High-risk features
     17p deletion only13.7
     TP53 mutation only27.4
     Both TP53 mutation and 17p deletion27.4
     NOTCH1 mutation311.1
    Bulky adenopathy829.6
    Median β2 microglobulin (range), mg/L5.2 (2.4-14.6)
    • SLL, small lymphocytic lymphoma.

    • * One patient’s diagnosis was later reclassified to lymphoplasmacytic lymphoma.

    • Bulky indicates the presence of ≥1 node with a diameter ≥5 cm.

  • Table 2.

    Adverse events experienced by at least 2 patients on study, ordered by decreasing frequency of occurrence of any grade toxicity

    EventAny gradeGrade 3 or 4
    ALT increase17 (63)14 (52)
    AST increase17 (63)11 (41)
    Decreased neutrophil count13 (48)9 (33)
    Fever11 (41)0 (0)
    Colitis/diarrhea10 (37)4 (15)
    Fatigue8 (30)0 (0)
    Rash (maculopapular)8 (30)2 (7)
    Nausea7 (26)0 (0)
    Infusion-related reaction6 (22)1 (4)
    Myalgia5 (19)1 (4)
    Abdominal pain4 (15)0 (0)
    Chills4 (15)0 (0)
    Anemia3 (11)1 (4)
    Constipation3 (11)0 (0)
    Cough3 (11)0 (0)
    Dysgeusia3 (11)0 (0)
    Limb edema3 (11)0 (0)
    Other infections and infestations3 (11)2 (7)
    Pneumonitis3 (11)2 (7)
    Vomiting3 (11)0 (0)
    Increased alkaline phosphatase2 (7)1 (4)
    Anorexia2 (7)0 (0)
    Increased bilirubin2 (7)0 (0)
    Bronchial infection2 (7)0 (0)
    Dyspnea2 (7)0 (0)
    Gastroesophageal reflux disease2 (7)0 (0)
    Hyponatremia2 (7)2 (7)
    Lung infection2 (7)2 (7)
    Malaise2 (7)0 (0)
    Acneiform rash2 (7)0 (0)
    Weight loss2 (7)1 (4)
    Decreased white blood cell count2 (7)0 (0)
    • Data are n (%).