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

Not Recruiting

Trial ID: NCT01203930


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.

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

Stanford Investigator(s)

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Jason Gotlib

Professor of Medicine (Hematology)


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

      - Massive nodes (ie, > 10 cm in longest diameter) or progressive or symptomatic

      - 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.


drug: Rituximab

drug: Idelalisib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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