A clinical trial which compares the safety and efficacy of chemotherapy (Rituximab and Bendamustine ) combined with Duvelisib, the study treatment, or a placebo in patients who have previously treated Indolent Non-Hodgkin Lymphoma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1.?18 years of age
2. 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)
3. Have received the following systemic treatments for iNHL:
- an anti-CD20 antibody; and
- chemotherapy
4. 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)
5. Eastern Cooperative Oncology Group (ECOG) performance status ?2 (corresponds to Karnofsky Performance Status [(KPS) ?60%])
For full inclusion criteria list, refer to protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

1. Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
2. Refractory to BR, defined as:
- Progression of disease while receiving or within 6 months of completing bendamustine + rituximab therapy
3. Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
4. Received prior allogeneic transplant
5. Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
6. Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
7. History of tuberculosis treatment within the two years prior to randomization
8. History of chronic liver disease, veno-occlusive disease, or alcohol abuse
9. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) daily (QD)
10. Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
11. Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
12. Concurrent active malignancy other than adequately treated non-melanoma skin cancer or lentigo maligna without evidence of invasive disease or adequately treated carcinoma in situ without evidence of disease
13. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
For full exclusion criteria list, refer to protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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