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

Phase 3

Terminated

• Conditions: Indolent Non-Hodgkin's Lymphomas
• Interventions: Drug: Idelalisib; Drug: Rituximab; Drug: Bendamustine; Drug: Placebo

• Registration Number: NCT01732926
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-26
• Study Start: 2013-01-02
• Primary Completion: 2016-05-17
• Study Completion: 2016-05-17
• Status Verified: 2017-03
• Results First Submitted: 2017-03-30
• Results First Submitted QC: 2017-03-30
• Results First Posted: 2017-05-11
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 475

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)
  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.
• Prior treatment with bendamustine that was not effective.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)		PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)		Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR 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 (OS)		Overall survival is defined as the interval from randomization to death from any cause.
Complete Response Rate (CR)		Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.

Trial Locations

Locations (141)

Clearview Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

Ironwood Cancer and Research Center; 🇺🇸 Chandler, Arizona, United States

Comprehensive Blood and Cancer Center (Bakersfield); 🇺🇸 Bakersfield, California, United States

Saint Jude Heritage Healthcare (TORI); 🇺🇸 Fullerton, California, United States

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

Cancer Care Associates; 🇺🇸 Redondo Beach, California, United States

San Luis Obispo Oncology and Hematology; 🇺🇸 San Luis Obispo, California, United States

Cancer Center of Santa Barbara; 🇺🇸 Santa Barbara, California, United States

Central Coast Medical Oncology Group; 🇺🇸 Santa Maria, California, United States

St Joseph Heritage Healthcare System; 🇺🇸 Santa Rosa, California, United States

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