This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01744691
First received: December 3, 2012
Last updated: January 9, 2017
Last verified: January 2017
Results First Received: May 21, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia With 17p Deletion
Small Lymphocytic Lymphoma With 17p Deletion
Intervention: Drug: Ibrutinib

  Participant Flow
  Hide Participant Flow

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
One hundred forty-five subjects were enrolled and 144 subjects received at least 1 dose of PCI-32765 and constitute the all treated population and the safety analysis set.

Reporting Groups
  Description
Ibrutinib

All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.


Participant Flow:   Overall Study
    Ibrutinib
STARTED   144 [1] 
COMPLETED   101 [2] 
NOT COMPLETED   43 
Progressive Disease                18 
Unacceptable toxicity, AE or death                18 
Withdrawal of consent for treatment                3 
Physician Decision                4 
[1] Participants who received study treatment
[2] Participants who were on study treatment at the time of the primary analysis



  Baseline Characteristics
  Hide Baseline Characteristics

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.
One hundred forty-five subjects were enrolled and 144 subjects received at least 1 dose of PCI-32765 and constitute the all treated population and the safety analysis set.

Reporting Groups
  Description
PCI-32765

All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.


Baseline Measures
   PCI-32765 
Overall Participants Analyzed 
[Units: Participants]
 144 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      75  52.1% 
>=65 years      69  47.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.4  (9.9) 
Gender 
[Units: Participants]
Count of Participants
 
Female      48  33.3% 
Male      96  66.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months ]

2.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (AEs)   [ Time Frame: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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. Alvina Chu
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: NCT01744691     History of Changes
Other Study ID Numbers: PCYC-1117-CA
2012-004476-19 ( EudraCT Number )
Study First Received: December 3, 2012
Results First Received: May 21, 2015
Last Updated: January 9, 2017