A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

Inclusion Criteria

• •Histologically or cytologically confirmed CLL or SLL.
• •Age ≥ 65
• •Presence of measurable lymphadenopathy (defined as the presence of ≥1 nodal lesion that measures ≥ 1.5 cm in the longest diameter (LD) and ≥ 1.0 cm in the longest perpendicular diameter (LPD) as assessed by physical exam, computed tomography (CT) or magnetic resonance imaging (MRI)).
• •CLL - Binet Stage C or Rai Stage III or IV or has active disease defined by meeting at least one of the following criteria:
• •* Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
• •* Massive (ie, \> 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
• •* Massive nodes (ie, \> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
• •* Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time of less than 6 months
• •* Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy
• •* At least one of the following disease-related symptoms:
• •* Unintentional weight loss ≥ 10% within the previous 6 months
• •* Significant fatigue
• •* Fevers \> 100.4 F for ≥ 2 weeks without other evidence of infection
• •* Night sweats for ≥ 1 month without evidence of infection
• •SLL - has active disease as defined above for CLL, except the lymphocytosis criterion does not apply
• •World Health Organization (WHO) Performance Status of ≤ 2
• •For men of child-bearing potential, willing to use adequate methods of contraception for the entire duration of the study
• •Able to provide written informed consent