A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma (BRAVURA)

Inclusion Criteria:

Diagnosis of iNHL with one of the following histologic sub-types and grade:

Follicular lymphoma (FL)Grade 1, 2, or 3a
Small lymphocytic lymphoma (SLL)
Marginal zone lymphoma (MZL)( splenic, nodal, or extranodal)

Have received the following systemic treatments for iNHL:

an anti-CD20 antibody; and
chemotherapy
At least 1 measurable disease lesion > 1.5 cm in at least one dimension by computed tomography (CT)/CT-PET or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (corresponds to Karnofsky Performance Status [(KPS) ≥60%])

Exclusion Criteria:

Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL

Refractory to bendamustine + rituximab therapy or single-agent bendamustine 120 mg/m2, with refractory defined as:

- Progression of disease while receiving or within 6 months of completing treatment

Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
Received prior allogeneic transplant
Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
History of tuberculosis treatment within the two years prior to randomization
History of chronic liver disease, veno-occlusive disease, or alcohol abuse
Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) daily (QD)
Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
Concurrent active malignancy other than adequately treated non-melanoma skin cancer or lentigo maligna without evidence of invasive disease or adequately treated cervical carcinoma in situ without evidence of disease
History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
History of progressive multifocal leukoencephalopathy