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A Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (RESONATE™-2)

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01722487
First received: October 29, 2012
Last updated: May 4, 2016
Last verified: May 2016
Results First Received: March 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions: Drug: Ibrutinib
Drug: Chlorambucil

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ibrutinib Ibrutinib 420 mg daily.
Chlorambucil Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles

Participant Flow:   Overall Study
    Ibrutinib   Chlorambucil
STARTED   136   133 
COMPLETED   134 [1]   126 [1] 
NOT COMPLETED   2   7 
[1] Participants who were still on study or died at study closure



  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.
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Reporting Groups
  Description
Ibrutinib Ibrutinib 420 mg daily.
Chlorambucil Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
Total Total of all reporting groups

Baseline Measures
   Ibrutinib   Chlorambucil   Total 
Overall Participants Analyzed 
[Units: Participants]
 136   133   269 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   0   0   0 
>=65 years   136   133   269 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.1  (5.67)   73.4  (5.95)   73.3  (5.81) 
Gender 
[Units: Participants]
     
Female   48   52   100 
Male   88   81   169 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   PFS (Progression Free Survival)   [ Time Frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month. ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month. ]

3.  Secondary:   ORR (Overall Response Rate)   [ Time Frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month. ]

4.  Secondary:   Proportion of Sustained Hemoglobin Improvement   [ Time Frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month. ]

5.  Secondary:   Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia   [ Time Frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month. ]

6.  Secondary:   Proportion of Sustained Platelet Improvement   [ Time Frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month. ]

7.  Secondary:   Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia   [ Time Frame: Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month. ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Lori Styles, Medical Monitor
Organization: Pharmacyclics LLC
phone: +1 (408) 215-3770
e-mail: lstyles@pcyc.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01722487     History of Changes
Other Study ID Numbers: PCYC-1115-CA
2012-003967-23 ( EudraCT Number )
Study First Received: October 29, 2012
Results First Received: March 31, 2016
Last Updated: May 4, 2016