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Efficacy and Safety of Idelalisib (GS-1101; CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01659021
First received: August 3, 2012
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: February 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: Idelalisib
Drug: Ofatumumab

  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 North America, Europe, and Australia. The first participant was screened on 04 December 2012. The last study visit up to the data cut date occurred on 02 May 2016.

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

Reporting Groups
  Description
Idelalisib+Ofatumumab

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Ofatumumab

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation


Participant Flow:   Overall Study
    Idelalisib+Ofatumumab   Ofatumumab
STARTED   174   87 
Randomized and Treated   173   86 
COMPLETED   86   50 
NOT COMPLETED   88   37 
Adverse Event                2                3 
Lost to Follow-up                1                0 
Other?                1                1 
Physician Decision                32                16 
Withdrawal by Subject                18                16 
Still on Study                34                1 



  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: participants who are randomized in the study with treatment group designated according to initial randomization.

Reporting Groups
  Description
Idelalisib+Ofatumumab

Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Ofatumumab

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Total Total of all reporting groups

Baseline Measures
   Idelalisib+Ofatumumab   Ofatumumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 174   87   261 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 174   87   261 
   67  (9.0)   67  (9.7)   67  (9.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 174   87   261 
Female      50  28.7%      25  28.7%      75  28.7% 
Male      124  71.3%      62  71.3%      186  71.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 174   87   261 
Hispanic or Latino      7   4.0%      3   3.4%      10   3.8% 
Not Hispanic or Latino      141  81.0%      74  85.1%      215  82.4% 
Unknown or Not Reported      26  14.9%      10  11.5%      36  13.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White       
Participants Analyzed 
[Units: Participants]
 174   87   261 
White   149   71   220 
Black or African American       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Black or African American   0   4   4 
Native Hawaiian or Other Pacific Islander       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Native Hawaiian or Other Pacific Islander   1   0   1 
Asian       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Asian   2   0   2 
Other       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Other   2   3   5 
Not Permitted       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Not Permitted   20   9   29 
Region of Enrollment 
[Units: Participants]
     
Canada       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Canada   13   9   22 
Sweden       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Sweden   4   2   6 
Belgium       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Belgium   5   1   6 
United States       
Participants Analyzed 
[Units: Participants]
 174   87   261 
United States   64   29   93 
Ireland       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Ireland   7   4   11 
Denmark       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Denmark   4   0   4 
Poland       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Poland   27   9   36 
United Kingdom       
Participants Analyzed 
[Units: Participants]
 174   87   261 
United Kingdom   11   6   17 
Australia       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Australia   16   13   29 
France       
Participants Analyzed 
[Units: Participants]
 174   87   261 
France   15   9   24 
Spain       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Spain   8   5   13 
Time Since Diagnosis [1] 
[Units: Months]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 173   86   259 
   101.0  (60.21)   94.3  (52.51)   98.8  (57.75) 
[1] Only participants who were randomized and treated are included.
17p deletion and/or TP53 mutation 
[Units: Participants]
Count of Participants
     
Either       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Either   70   33   103 
Neither       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Neither   104   54   158 
Immunoglobulin heavy chain variable region (IGHV) mutation status 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 174   87   261 
Mutated      37  21.3%      19  21.8%      56  21.5% 
Unmutated      137  78.7%      68  78.2%      205  78.5% 
Disease Status [1] 
[Units: Participants]
Count of Participants
     
Refractory       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Refractory   82   47   129 
Relapsed       
Participants Analyzed 
[Units: Participants]
 174   87   261 
Relapsed   92   40   132 
[1] Refractory: CLL progression < 6 months from completion of prior therapy; Relapsed: CLL progression ≥ 6 months from completion of prior therapy.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival   [ Time Frame: Up to 37 months ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Up to 37 months ]

3.  Secondary:   Lymph Node Response Rate   [ Time Frame: Up to 37 months ]

4.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

5.  Secondary:   Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation   [ Time Frame: Up to 37 months ]

6.  Secondary:   Complete Response Rate   [ Time Frame: Up to 37 months ]


  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
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  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: NCT01659021     History of Changes
Other Study ID Numbers: GS-US-312-0119
2012-001236-65 ( EudraCT Number )
Study First Received: August 3, 2012
Results First Received: February 14, 2017
Last Updated: February 14, 2017