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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732913
First Posted: November 26, 2012
Last Update Posted: May 11, 2017
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.
Information provided by (Responsible Party):
Gilead Sciences
Results First Submitted: March 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Indolent Non-Hodgkin's Lymphomas
Interventions: Drug: Placebo
Drug: Rituximab
Drug: Idelalisib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 16 January 2013. The last study visit occurred on 18 May 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
385 participants were screened.

Reporting Groups
  Description
Idelalisib + Rituximab Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Placebo + Rituximab Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions

Participant Flow:   Overall Study
    Idelalisib + Rituximab   Placebo + Rituximab
STARTED   198   97 
COMPLETED [1]   42   28 
NOT COMPLETED   156   69 
Study Terminated by Sponsor                105                55 
Withdrawal by Subject                27                4 
Physician Decision                14                7 
Other                7                1 
Initiation of Other Anti-Cancer Therapy                3                2 
[1] Completed = reached primary efficacy endpoint of progressive disease or death



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment

Reporting Groups
  Description
Idelalisib + Rituximab Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Placebo + Rituximab Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
Total Total of all reporting groups

Baseline Measures
   Idelalisib + Rituximab   Placebo + Rituximab   Total 
Overall Participants Analyzed 
[Units: Participants]
 198   97   295 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (11.4)   67  (11.4)   65  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      99  50.0%      48  49.5%      147  49.8% 
Male      99  50.0%      49  50.5%      148  50.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian   35   17   52 
Black or African American   5   4   9 
White   123   54   177 
Other   3   3   6 
Not Permitted   32   19   51 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   12   3   15 
Not Hispanic or Latino   150   75   225 
Unknown or Not Reported   36   19   55 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Russian Federation   7   2   9 
Singapore   5   4   9 
Romania   1   0   1 
Hungary   24   6   30 
United States   65   34   99 
Japan   23   9   32 
United Kingdom   3   1   4 
Portugal   3   1   4 
Spain   6   0   6 
Czech Republic   2   0   2 
Sweden   6   2   8 
Taiwan   1   1   2 
Poland   5   7   12 
Korea, Republic of   4   2   6 
Italy   7   4   11 
Israel   3   0   3 
Australia   7   6   13 
France   25   17   42 
Germany   1   1   2 


  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: ]

2.  Secondary:   Overall Response Rate   [ Time Frame: ]

3.  Secondary:   Lymph Node Response Rate   [ Time Frame: ]

4.  Secondary:   Complete Response Rate   [ Time Frame: ]

5.  Secondary:   Overall Survival   [ Time Frame: ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
e-mail: ClinicalTrialDisclosures@gilead.com



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732913     History of Changes
Other Study ID Numbers: GS-US-313-0124
First Submitted: November 14, 2012
First Posted: November 26, 2012
Results First Submitted: March 30, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017



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