Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Condition: Follicular Lymphoma; Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Rituximab
Intervention description: 150 tablets administered orally twice daily; 375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Intervention MeSH terms: Rituximab; Idelalisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Indolent Non-Hodgkin Lymphoma; FL; SLL

Summary:

      The primary objective of this study is to evaluate the overall response rate (ORR) and
      complete response (CR) rate to treatment with idelalisib in combination with rituximab in
      previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma
      (SLL).

      An increased rate of deaths and serious adverse events (SAEs) among participants with
      front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma
      (iNHL) treated with idelalisib in combination with standard therapies was observed by the
      independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3
      studies. Gilead reviewed the unblinded data and terminated those studies in agreement with
      the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
      All front-line studies of idelalisib, including this study, were also terminated.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed diagnosis of B-cell lymphoma

          -  No previous systemic treatment for lymphoma

          -  Subject demonstrates need for treatment for lymphoma

          -  Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy

          -  Adequate performance status

          -  Required baseline laboratory data within protocol-specified parameters

        Key Exclusion Criteria:

          -  Known history of transformed lymphoma or diffuse large cell lymphoid malignancy

          -  Known history of, or clinically apparent, central nervous system (CNS) lymphoma or
             leptomeningeal lymphoma

          -  Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
             enrollment

          -  Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic
             active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis,
             cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing
             extrahepatic obstruction caused by cholelithiasis

          -  Ongoing inflammatory bowel disease

          -  Known human immunodeficiency virus (HIV) infection

          -  History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

          -  Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg
             prednisone or equivalent/day) with the exception of the use of topical, enteric, or
             inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for
             autoimmune anemia and/or thrombocytopenia

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.