Safety of PCI-32765 in Chronic Lymphocytic Leukemia

This study has been completed.
Information provided by (Responsible Party):
Pharmacyclics Identifier:
First received: April 13, 2010
Last updated: February 13, 2014
Last verified: February 2014
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: B-cell Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
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
There are total 133 subjects enrolled however one subject never received treatment. Therefore, number of subjects "Started" the study is listed as 132 subjects.

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

Reporting Groups
PCI-32765 PCI-32765: 420 mg daily or 840 mg daily.
Food Effect Cohort PCI-32765: 420 mg daily

Participant Flow:   Overall Study
    PCI-32765     Food Effect Cohort  
STARTED     116     16  
COMPLETED     79     16  
NOT COMPLETED     37     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.
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Reporting Groups
PCI-32765 PCI-32765: 420 mg daily or 840 mg daily
Food Effect Cohort PCI-32765: 420 mg daily
Total Total of all reporting groups

Baseline Measures
    PCI-32765     Food Effect Cohort     Total  
Number of Participants  
[units: participants]
  116     16     132  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     42     9     51  
>=65 years     74     7     81  
[units: participants]
Female     32     2     34  
Male     84     14     98  

  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (AEs)   [ Time Frame: From first dose to within 30 days of last dose of PCI-32765 ]

2.  Secondary:   Food Effect Cohort Assessments   [ Time Frame: Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design. ]

3.  Secondary:   Progression Free Survival Rate at 24 Months   [ Time Frame: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). ]

4.  Secondary:   Percentage of Participants Achieving Response   [ Time Frame: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). ]

  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: Danelle James
Organization: Pharmacyclics
phone: 855-427-8846

No publications provided by Pharmacyclics

Publications automatically indexed to this study:

Responsible Party: Pharmacyclics Identifier: NCT01105247     History of Changes
Other Study ID Numbers: PCYC-1102-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
Study First Received: April 13, 2010
Results First Received: December 16, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board