Clinical trial · Interventional
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)
A Phase 3, Randomized, Double-blind Study of Duvelisib Administered in Combination With Rituximab and Bendamustine vs Placebo Administered in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma
NCT02576275CI-TRIAL-00050705withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.
Summary
Brief summary (as posted)
This study will evaluate the efficacy and safety of duvelisib in combination with bendamustine and rituximab (DBR) vs placebo in combination with bendamustine and rituximab (PBR) in subjects with previously-treated indolent non-Hodgkin lymphoma (iNHL).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Indolent Non-Hodgkin's Lymphoma | Indolent Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Duvelisib | Drug | Duvelisib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Duvelisib + Rituximab + Bendamustine
- description
- Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Bendamustine is administered as an intravenous (IV) infusion and is supplied for injection in single-use vials at two strengths, 25 mg and 100 mg. Rituximab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
- interventionNames
- Drug: Duvelisib
- Drug: Rituximab
- Drug: Bendamustine
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Rituximab + Bendamustine
- description
- Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules of duvelisib. Bendamustine is administered as an IV infusion and is supplied for injection in single-use vials at two strengths, 25 mg and 100 mg. Rituximab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.