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

Disease Information

Descriptive Information
Brief Title † A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL
Official Title † 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
Brief Summary This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Overall Response Rate (ORR)
Secondary Outcome Measure † Overall Safety of Idelalisib
Condition † Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)
Intervention † DrugIdelalisib
Study Arms / Comparison Groups Idelalisib This arm consists of 2 cohorts. Participants in Cohort 1 will receive idelalisib for up to twelve 28-day cycles (or development of unacceptable toxicity) plus rituximab (8 doses through the end of Cycle 2). Upon completion of twelve 28-cycles, participants are eligible to remain on idelalisib in a continuation protocol. Participants in Cohort 2 will receive idelalisib until disease progression or development of unacceptable toxicity.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 105
Start Date † October 2010
Completion Date June 2016
Primary Completion Date August 2015
Eligibility Criteria † Key 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 Key Exclusion Criteria: - Prior therapy for CLL or SLL, except corticosteroids for symptom relief - Treatment with a short course of corticosteroids for symptom relief within 1-week prior to Visit 1 - Known active central nervous system involvement of the malignancy - Ongoing active, serious infection requiring systemic therapy. Patients may be receiving prophylactic antibiotics and antiviral therapy at the discretion of the treating physician. - Serum creatinine ≥ 2.0 mg/dL - Serum bilirubin ≥ 2 mg/dL (unless due to Gilbert's syndrome) or serum transaminases (ie, aspartate aminotransferase (AST), alanine aminotransferase (ALT)) ≥ 2 x upper limit of normal - Positive test for human immunodeficiency virus (HIV) antibodies - Active hepatitis B or C (confirmed by ribonucleic acid (RNA) test). Patients with serologic evidence of prior exposure are eligible. - History of a non-CLL malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to study entry, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender All
Ages 65 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01203930
Organization ID 101-08
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Gilead Sciences
Collaborators ††
Investigators † Study Director: Gilead Study Director, Gilead Sciences
Information Provided By
Verification Date May 2017
First Received Date † September 15, 2010
Last Updated Date May 19, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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