Imexon for Relapsed Follicular and Aggressive Lymphomas (ULYM11011)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01314014
First received: March 10, 2011
Last updated: May 29, 2014
Last verified: May 2014
Results First Received: May 29, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Follicular Lymphoma
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
Lymphoplasmacytic Lymphoma
Diffuse Large B Cell Lymphoma
Mantle Cell Lymphoma
Burkitt's Lymphoma
Intervention: Drug: Imexon

  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
Recruitment for this study occured at two academic medical centers (University of Rochester and Arizona Cancer Center) from June 7, 2011 through March 4, 2013.

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
Imexon

Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.

Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.


Participant Flow:   Overall Study
    Imexon  
STARTED     22  
COMPLETED     22 [1]
NOT COMPLETED     0  
[1] Treatment continued for as long as the subject derived benefit.



  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
Imexon

Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.

Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.


Baseline Measures
    Imexon  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Median ( Full Range )
  64  
  ( 43 to 92 )  
Gender  
[units: participants]
 
Female     9  
Male     13  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     22  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     20  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy of Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas   [ Time Frame: One year ]

2.  Secondary:   Progression Free Survival in Relapsed/Refractory Indolent and Aggressive Lymphomas   [ Time Frame: Until disease progression or death ]


  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: Paul M. Barr, MD
Organization: James P. Wilmot Cancer Center, University of Rochester
phone: 585-273-3258
e-mail: Paul_Barr@urmc.rochester.edu


No publications provided by University of Rochester

Publications automatically indexed to this study:

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01314014     History of Changes
Other Study ID Numbers: 36191
Study First Received: March 10, 2011
Results First Received: May 29, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration