Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Condition: B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Rituximab
Intervention description: 150 mg tablets administered orally twice daily; 375 mg/m^2 administered intravenously once weekly x 8 weeks
Intervention MeSH terms: Rituximab; Idelalisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; CLL

Summary:

      The primary objective of this study is to evaluate overall response rate (ORR) following
      treatment with idelalisib plus rituximab in participants with previously untreated chronic
      lymphocytic leukemia (CLL) with 17p deletion.

      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 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:

          -  Documented diagnosis of B-cell CLL, according to International Workshop on Chronic
             Lymphocytic Leukemia 2008

          -  Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ
             hybridization (FISH) testing

          -  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

          -  History of a non-CLL malignancy except for the following:

               -  the malignancy has been in remission without treatment for ≥ 5 years prior to
                  enrollment, or

               -  carcinoma in situ of the cervix, or

               -  adequately treated basal or squamous cell skin cancer or other localized
                  non-melanoma skin cancer, or

               -  asymptomatic prostate cancer without known metastatic disease and with no current
                  requirement for therapy or requiring only hormonal therapy and with normal
                  prostate specific antigen for ≥ 1 year prior to enrollment, or

               -  ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or

               -  other adequately treated Stage 1 or 2 cancer currently in complete remission

          -  Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
             enrollment

          -  Ongoing liver injury

          -  History of noninfectious 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 enrollment

          -  Prior or ongoing clinically significant illness, medical condition, surgical history,
             physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.