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PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303953
First received: March 15, 2006
Last updated: April 23, 2014
Last verified: April 2013
Results First Received: February 28, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Intervention: Drug: belinostat

  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
No text entered.

Reporting Groups
  Description
PXD101 Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.

Participant Flow:   Overall Study
    PXD101  
STARTED     22  
Eligible     21  
Eligible and Treated     20  
COMPLETED     3  
NOT COMPLETED     19  
Ineligible                 1  
Death                 1  
Adverse Event                 4  
Lack of Efficacy                 12  
Physician Decision                 1  



  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.
No text entered.

Reporting Groups
  Description
PXD101 Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.

Baseline Measures
    PXD101  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Median ( Full Range )
  68.9  
  ( 51.6 to 82.9 )  
Gender  
[units: participants]
 
Female     9  
Male     11  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     19  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     19  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)   [ Time Frame: assessed at week 8, and every 3 months for 3 years ]

2.  Secondary:   Overall Survival   [ Time Frame: assessed every 3 months for 3 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: assessed at week 8, then every 3 months for 3 years ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lymphoma Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623
e-mail: mleblanc@fhcrc.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303953     History of Changes
Other Study ID Numbers: NCI-2009-01096, NCI-2009-01096, CDR0000462614, S0520, S0520, U10CA032102
Study First Received: March 15, 2006
Results First Received: February 28, 2012
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration