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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732913
Recruitment Status : Terminated
First Posted : November 26, 2012
Results First Posted : May 11, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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).


Condition or disease Intervention/treatment Phase
Indolent Non-Hodgkin's Lymphomas Drug: Placebo Drug: Rituximab Drug: Idelalisib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 16, 2013
Actual Primary Completion Date : May 18, 2016
Actual Study Completion Date : May 18, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rituximab + idelalisib
Participants will receive rituximab + idelalisib.
 Drug: Rituximab
375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
Other Names:
  • Rituxan®
  • MabThera®

Drug: Idelalisib
150 mg tablets administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®
Placebo Comparator: 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.
 Drug: Placebo
Tablets administered orally twice daily

Drug: Rituximab
375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
Other Names:
  • Rituxan®
  • MabThera®

Drug: Idelalisib
150 mg tablets administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. Overall Survival
    Overall survival is defined as the interval from randomization to death from any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732913


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732913    
Other Study ID Numbers: GS-US-313-0124
First Posted: November 26, 2012    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: November 16, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
iNHL
indolent NHL
follicular lymphoma
CAL-101
Rituximab
Small lymphocytic lymphoma
lymphoplasmacytoid lymphoma
Waldenstrom macroglobulinemia
 LPL
WM
Marginal zone lymphoma
MZL
SLL
FL
GS-1101
idelalisib
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
 Idelalisib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action