A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Overview
- Phase
- Phase 3
- Intervention
- Idelalisib
- Conditions
- Indolent Non-Hodgkin's Lymphomas
- Sponsor
- Gilead Sciences
- Enrollment
- 295
- Locations
- 103
- Primary Endpoint
- Progression Free Survival
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
- •Follicular lymphoma (FL) Grade 1, 2, or 3a
- •Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis
- •Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
- •Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
Exclusion Criteria
- •History of lymphoid malignancy other than those allowed per inclusion criteria
- •Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •Received previous treatment with rituximab that was not effective.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Rituximab + idelalisib
Participants will receive rituximab + idelalisib.
Intervention: Idelalisib
Rituximab + idelalisib
Participants will receive rituximab + idelalisib.
Intervention: Rituximab
Rituximab + Placebo
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Intervention: Placebo
Rituximab + Placebo
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Intervention: Rituximab
Rituximab + Placebo
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Intervention: Idelalisib
Outcomes
Primary Outcomes
Progression Free Survival
Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
Secondary Outcomes
- Overall Response Rate
- Complete Response Rate
- Lymph Node Response Rate
- Overall Survival