A Multicenter Phase 2 Study of PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01744691
First received: December 3, 2012
Last updated: May 21, 2015
Last verified: May 2015
Results First Received: May 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia With 17p Deletion
Small Lymphocytic Lymphoma With 17p Deletion
Intervention: Drug: PCI-32765

  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
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.


Participant Flow:   Overall Study
    PCI-32765  
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
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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.
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  
Number of Participants  
[units: participants]
  144  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     75  
>=65 years     69  
Age  
[units: years]
Mean (Standard Deviation)
  64.4  (9.9)  
Gender  
[units: participants]
 
Female     48  
Male     96  



  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: The median time on study for all treated participants is 11.5 (range 0.5 - 16.6) 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
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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
No text entered.


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


No publications provided


Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT01744691     History of Changes
Other Study ID Numbers: PCYC-1117-CA, 2012-004476-19
Study First Received: December 3, 2012
Results First Received: May 21, 2015
Last Updated: May 21, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Ministry of Health
Turkey: Clinical Drug Research Department (Klinik Ilaç Arsatirmalari Sube Mudurlugu) (MHDP)
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration