A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination Wit… (NCT02576275) | Clinical Trial Compass
WithdrawnPhase 3
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)
Stopped: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.
United States0Started 2015-12
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immunosupp…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From date of enrollment until the date of first documentation of progression or date of death from any cause, whatever came first, assessed up to 78 months