Trial Search Results

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

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 currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Intervention(s):

  • Drug: Idelalisib
  • Drug: Rituximab

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

65 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting