A Phase 2 Single Arm Study to Investigate the Safety and Clinical Activity of Idelalisib Alone and in Combination With Rituximab in Elderly Subjects With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
The purpose of this study is to see if an investigational drug named CAL-101, when given in combination with rituximab (also known as Rituxan), is safe to give to people with previously untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. "Investigational" means that this study drug is being tested in people and has not been approved by the United States Food and Drug Administration (FDA).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Idelalisib
- drug : Rituximab
Phase: Phase 2
Ages Eligible For Study:
- 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