Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
Condition: Follicular Lymphoma; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma; Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell; Waldenstrom Macroglobulinemia
Intervention: Idelalisib
Intervention description: Idelalisib 150 mg tablet administered orally twice daily
Intervention MeSH terms: Idelalisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: indolent Non-Hodgkin Lymphoma; Non-Hodgkin Lymphoma; iNHL; NHL; GS-1101; CAL-101; PI3K; Phosphatidylinositol 3-kinase; Follicular Lymphoma (FL); Small lymphocytic lymphoma (SLL); Lymphoplasmacytoid lymphoma (LPL); Marginal zone lymphoma (MZL)

Summary:

      The primary objective will be to assess the overall response rate and to evaluate the
      efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated
      indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to
      alkylating-agent-containing chemotherapy.

      Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg
      taken twice per day. Treatment with idelalisib can continue in compliant participants as long
      as the study is still ongoing and the participants appear to be benefiting from treatment
      with acceptable safety.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group [ECOG]
             performance score of 0, 1, or 2)

          -  Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
             to the following:

               -  Follicular lymphoma (FL)

               -  Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at
                  the time of diagnosis and on baseline laboratory assessment performed within 4
                  weeks prior to the start of study drug administration

               -  Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms
                  Macroglobulinemia (WM)

               -  Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)

          -  Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for
             iNHL

          -  Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
             malignancy

          -  Prior treatment with rituximab and with an alkylating agent (eg, bendamustine,
             cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for
             iNHL

          -  Lymphoma that is refractory to rituximab and to an alkylating agent

          -  Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2

          -  For men and women of childbearing potential, willingness to abstain from sexual
             intercourse or employ an effective method of contraception during the study drug
             administration and follow-up periods

          -  Willingness and ability to provide written informed consent and to comply with the
             protocol requirements

        Key Exclusion Criteria:

          -  Central nervous system or leptomeningeal lymphoma

          -  Known histological transformation from iNHL to diffuse large B-cell lymphoma

          -  History of a non-lymphoma malignancy except for the following: adequately treated
             local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
             superficial bladder cancer, localized prostate cancer, 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

          -  Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral
             upper respiratory tract infections) at the time of initiation of study treatment

          -  Pregnancy or breastfeeding

          -  Ongoing alcohol or drug addiction

          -  Known history of drug-induced liver injury, chronic active hepatitis B infection,
             chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic
             steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by
             stones, cirrhosis of the liver, or portal hypertension

          -  History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

          -  Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may
             be using topical or inhaled corticosteroids.

          -  Prior therapy with idelalisib

          -  Exposure to another investigational drug within 3 weeks prior to start of study
             treatment

          -  Concurrent participation in another therapeutic treatment trial

          -  Prior or ongoing clinically significant illness, medical condition, surgical history,
             physical finding, ECG finding, or laboratory abnormality that, in the investigator's
             opinion, could affect the safety of the participant, alter the absorption,
             distribution, metabolism or excretion of the study drug, or impair the assessment of
             study results

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.