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Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Talon Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00495079
First received: June 28, 2007
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
Results First Received: March 15, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Lymphoblastic Leukemia (ALL)
Intervention: Drug: Marqibo® (vincristine sulfate liposomes injection)

  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
Subjects were enrolled and treated at 22 sites in United States, Canada, Germany, Israel and United Kingdom. The first subject was infused on August 2, 2007. The last subject completed study on August 8, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2.25 mg/m^2 Marqibo administered intravenously via peripheral or central venous access over 60 minutes (+-10 minutes)

Reporting Groups
  Description
Marqibo Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).

Participant Flow:   Overall Study
    Marqibo  
STARTED     65  
COMPLETED     65  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Marqibo Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).

Baseline Measures
    Marqibo  
Number of Participants  
[units: participants]
 		  65  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     59  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation 		  36.3  ± 16.37  
Gender  
[units: participants]
 		 
Female     32  
Male     33  
Region of Enrollment  
[units: participants]
 		 
United States     53  
Canada     2  
Israel     6  
Germany     4  
United Kingdom     0  



  Outcome Measures
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1.  Primary:   Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)   [ Time Frame: Response assessment performed at the end of each 28 day course. ]
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2.  Primary:   Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation   [ Time Frame: Response assessment at the end of each 28 days course ]
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3.  Secondary:   Duration of CR + CRi   [ Time Frame: CR + CRi duration was calculated from the date the subject first met the definition of CR or CRi until the date of relapse ]
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4.  Secondary:   Overall Survival   [ Time Frame: unlimited ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Talon Therapeutics
phone: 650-588-6404
e-mail: info@talontx.com


No publications provided by Talon Therapeutics, Inc

Publications automatically indexed to this study:


Responsible Party: Talon Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00495079     History of Changes
Other Study ID Numbers: HBS407
Study First Received: June 28, 2007
Results First Received: March 15, 2012
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration