Dose Optimization Study of Idelalisib in Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Idelalisib
Intervention description: Idelalisib tablet administered orally
Intervention MeSH terms: Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: As of protocol amendment 5, the Idelalisib 100 mg arm is closed to enrollment.
Masking: None (Open Label)
Masking description: Double-blind: Prior to protocol amendment 5; Open-label: Participants enrolled as of protocol amendment 5
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to establish a safe and effective dosing regimen of
      idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no
      other therapeutic options.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed diagnosis of B-cell follicular lymphoma (FL), and grade
             limited to 1, 2, or 3a based on criteria established by the World Health Organization
             (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissues

          -  Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL
             and have no other available therapeutic options. Note: Rituximab maintenance is not
             routinely considered a separate line of therapy when it is given as part of the prior
             rituximab-containing regimen given over a number of cycles followed by maintenance.
             Rituximab monotherapy may be considered a separate line of therapy when disease
             relapse occurs between the initiation of rituximab monotherapy and the preceding line
             of therapy. If there are any ambiguities about eligibility, the site should consult
             with the medical monitor.

          -  Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification
             Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
             as the presence of ≥ 1 lesion that measures ≥ 1.5 cm in the longest dimension (LD) and
             ≥ 1.0 cm in the longest perpendicular dimension (LPD) as assessed by positron emission
             tomography-computed tomography (PET-CT), computed tomography (CT) or magnetic
             resonance imaging (MRI)

          -  Required baseline central laboratory data in protocol.

          -  For female individuals of childbearing potential and male individuals of reproductive
             potential, willingness to use a protocol- recommended method of contraception

          -  Lactating females must agree to discontinue nursing

          -  Willing and able to comply with scheduled visits, drug administration plan, imaging
             studies, laboratory tests, other study procedures, and study restrictions including
             mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)

        Key Exclusion Criteria:

          -  History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma)

          -  Known history of, or clinically apparent, central nervous system (CNS) lymphoma or
             leptomeningeal lymphoma.

          -  Known presence of intermediate- or high-grade myelodysplastic syndrome.

          -  Known history of serious allergic reaction including anaphylaxis or Stevens- Johnson
             syndrome/ toxic epidermal necrolysis

          -  History of a non-lymphoid malignancy except for protocol allowed exceptions

          -  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 virus (HBV),
             chronic active hepatitis C virus (HCV), alcoholic liver disease, non-alcoholic
             steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary
             cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis

          -  History of or ongoing drug-induced pneumonitis

          -  History of or 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

          -  Concurrent participation in another therapeutic clinical trial

          -  Prior treatment with phosphatidylinositol 3-kinase (PI3K) inhibitors

          -  Cytomegalovirus (CMV): Ongoing infection, treatment, or specifically CMV antiviral
             prophylaxis within 28 days prior to the screening visits CMV test

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.