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PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT01500733
Recruitment Status : Active, not recruiting
First Posted : December 28, 2011
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Leukemia, Lymphocytyc
CLL (Chronic Lymphocytic Leukemia)
SLL (Small Lymphocytic Lymphoma)
Intervention: Drug: PCI 32765

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Elderly Cohort Chronic lymphocytic leukemia patients 65 years or older
TP53 Cohort Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation

Participant Flow:   Overall Study
    Elderly Cohort   TP53 Cohort
STARTED   35   51 
COMPLETED   33   48 
NOT COMPLETED   2   3 



  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.
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Reporting Groups
  Description
Elderly Cohort Chronic lymphocytic leukemia patients 65 years or older
TP53 Cohort Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
Total Total of all reporting groups

Baseline Measures
   Elderly Cohort   TP53 Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   51   86 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1   2.9%      30  58.8%      31  36.0% 
>=65 years      34  97.1%      21  41.2%      55  64.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  45.7%      20  39.2%      36  41.9% 
Male      19  54.3%      31  60.8%      50  58.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      3   5.9%      3   3.5% 
Not Hispanic or Latino      35 100.0%      48  94.1%      83  96.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      2   3.9%      2   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   5.7%      4   7.8%      6   7.0% 
White      33  94.3%      44  86.3%      77  89.5% 
More than one race      0   0.0%      1   2.0%      1   1.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Overall Response Rate at 6 Months   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ahn, Inhye
Organization: National Heart Lung and Blood Institute
phone: +1 301 827 1203
e-mail: inhye.ahn@nih.gov


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


Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01500733     History of Changes
Other Study ID Numbers: 120035
12-H-0035
First Submitted: December 22, 2011
First Posted: December 28, 2011
Results First Submitted: May 10, 2018
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018