Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Phase 3

Terminated

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).

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
1. Follicular lymphoma (FL) Grade 1, 2, or 3a
2. Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Key

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.

Arm && Interventions

Group	Intervention	Description
Rituximab + Placebo	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.
Rituximab + idelalisib	Rituximab	Participants will receive rituximab + idelalisib.
Rituximab + idelalisib	Idelalisib	Participants will receive rituximab + idelalisib.
Rituximab + Placebo	Rituximab	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.
Rituximab + Placebo	Idelalisib	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall Response Rate		Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.
Complete Response Rate		Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
Lymph Node Response Rate		Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
Overall Survival		Overall survival is defined as the interval from randomization to death from any cause.

Locations (103): Clearview Cancer Institute
🇺🇸
Huntsville, Alabama, United States
Ironwood Cancer and Research Center
🇺🇸
Chandler, Arizona, United States
City of Hope Cancer Center
🇺🇸
Duarte, California, United States
Saint Jude Heritage Healthcare
🇺🇸
Fullerton, California, United States
Pacific Shores Medical Group
🇺🇸
Long Beach, California, United States
UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Cancer Care Associates
🇺🇸
Redondo Beach, California, United States
Cancer Center of Santa Barbara
🇺🇸
Santa Barbara, California, United States
Central Coast Medical Oncology Group
🇺🇸
Santa Maria, California, United States
Middlesex Hospital Cancer Center
🇺🇸
Middletown, Connecticut, United States
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Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States