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Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01325701
First received: February 2, 2011
Last updated: March 2, 2017
Last verified: March 2017
Results First Received: June 30, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Diffuse Large Cell B-lymphoma
Intervention: 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
A total of 78 subjects were enrolled: 70 were treated with PCI-32765 (ibrutinib) 560 mg daily, and 8 were treated with ibrutinib 840mg daily. All subjects received at least 1 dose of study drug.

Reporting Groups
  Description
PCI-32765: 560 mg Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
PCI-32765: 840 mg Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.

Participant Flow:   Overall Study
    PCI-32765: 560 mg   PCI-32765: 840 mg
STARTED   70   8 
COMPLETED   49   5 
NOT COMPLETED   21   3 
Adverse Event                12                0 
Protocol Violation                1                0 
Physician Decision                2                2 
Withdrawal by Subject                2                1 
Rollerover Extension Study                4                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.
A total of 78 subjects were enrolled: 70 in PCI-32765: 560 mg , and 8 in PCI-32765: 840 mg . All subjects received at least 1 dose of study drug.

Reporting Groups
  Description
PCI-32765: 560 mg Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
PCI-32765: 840 mg Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
Total Total of all reporting groups

Baseline Measures
   PCI-32765: 560 mg   PCI-32765: 840 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   8   78 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      38  54.3%      4  50.0%      42  53.8% 
>=65 years      32  45.7%      4  50.0%      36  46.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (13.40)   64.4  (13.96)   62.7  (13.38) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  28.6%      2  25.0%      22  28.2% 
Male      50  71.4%      6  75.0%      56  71.8% 
Region of Enrollment 
[Units: Participants]
     
United States   70   8   78 


  Outcome Measures
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1.  Primary:   Percentage of Patients With an Overall Response to Study Drug   [ Time Frame: The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months) ]

2.  Secondary:   Number of Patients With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Adverse events determined to be related to study drug are collected from first dose until study exit (approximately 3 years). ]

3.  Secondary:   Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765   [ Time Frame: Performed during the first month of receiving study drug. ]


  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
PCI-32765:840 mg:8 subjects were enrolled and followed through their 1st response assessment. Due to a lack of positive responses observed, enrollment was terminated for futility. Response rate should not be generalized due to small sample size.


  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. Darrin Beaupre
Organization: Pharmacyclics, Inc.
phone: 855-427-8846
e-mail: medinfo@pcyc.com


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

Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01325701     History of Changes
Other Study ID Numbers: PCYC-1106-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
Study First Received: February 2, 2011
Results First Received: June 30, 2016
Last Updated: March 2, 2017