Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Bendamustine; Rituximab; Placebo
Intervention description: 150 mg tablet administered orally twice daily; Administered intravenously at a starting dose of 90 mg/m^2 for up to 6 cycles. Dosing will be based on mg/m^2 of body surface area.; Single-use vials administered intravenously weekly starting at 375 mg/m^2 on Day 1 (Week 0) and 500 mg/m^2 thereafter for a total of 6 infusions; Placebo to match idelalisib administered orally twice daily
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the progression-free survival in
      participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise
      be suitable for bendamustine and rituximab treatment as standard of care.

      An increased rate of deaths and serious adverse events (SAEs) among participants with
      front-line 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 this study in agreement with the DMC recommendation and in consultation with
      the US Food and Drug Administration (FDA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented diagnosis of B-cell CLL, with diagnosis established according to
             International Workshop on Chronic Lymphocytic Leukemia (IWCLL)

          -  No prior therapy for CLL other than corticosteroids for disease complications

          -  CLL that warrants treatment

          -  Presence of measurable lymphadenopathy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

        Key Exclusion Criteria:

          -  Known histological transformation from CLL to an aggressive lymphoma (ie, Richter
             transformation)

          -  Known presence of myelodysplastic syndrome

          -  Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
             randomization

          -  Ongoing liver injury

          -  History of non-infectious pneumonitis

          -  Ongoing inflammatory bowel disease

          -  History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

          -  Ongoing immunosuppressive therapy other than corticosteroids

          -  Received last dose of study drug on another therapeutic clinical trial within 30 days
             prior to randomization

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.