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A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE™)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01578707
First received: April 11, 2012
Last updated: September 11, 2015
Last verified: September 2015
Results First Received: June 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions: Drug: ofatumumab
Drug: ibrutinib

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ofatumumab (Arm A)

An anti-CD20 monoclonal antibody

ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.

Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)

Ibrutinib (Arm B)

A Bruton Tyrosine Kinase Inhibitor

ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity


Participant Flow:   Overall Study
    Ofatumumab (Arm A)     Ibrutinib (Arm B)  
STARTED     196     195  
COMPLETED     196     195  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Ofatumumab (Arm A)

An anti-CD20 monoclonal antibody

ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.

Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)

Ibrutinib (Arm B)

A Bruton Tyrosine Kinase Inhibitor

ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Total Total of all reporting groups

Baseline Measures
    Ofatumumab (Arm A)     Ibrutinib (Arm B)     Total  
Number of Participants  
[units: participants]
  196     195     391  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     75     77     152  
>=65 years     121     118     239  
Age  
[units: years]
Mean (Standard Deviation)
  66.8  (8.88)     66.1  (10.15)     66.5  (9.53)  
Gender  
[units: participants]
     
Female     59     66     125  
Male     137     129     266  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   PFS (Progression Free Survival)   [ Time Frame: Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled. ]

2.  Secondary:   OS (Overall Survival)   [ Time Frame: OS analysis was conducted at the time of the interim PFS analysis, which was about 18 months after the first subject was enrolled. ]

3.  Secondary:   Hematological Improvements   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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. George Cole
Organization: Pharmacyclics, Inc.
phone: 408-990-7340
e-mail: gecole@pcyc.com


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

Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT01578707     History of Changes
Other Study ID Numbers: PCYC-1112-CA
2012-000694-23 ( EudraCT Number )
Study First Received: April 11, 2012
Results First Received: June 23, 2015
Last Updated: September 11, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
France: ANSM, National Safety Agency for Medicinal Product and Health Services
Ireland: Health Products Regulatory Authority
Italy: The Italian Medicines Agency
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency