Rasburicase in Patients at Risk for Tumor Lysis Syndrome

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00628628
First received: February 25, 2008
Last updated: May 31, 2013
Last verified: May 2013
Results First Received: May 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tumor Lysis Syndrome
Interventions: Drug: As Needed Rasburicase
Drug: Fixed Dose Rasburicase

  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 Period: January 28, 2008 to March 8, 2010. All participants were recruited in a medical clinic setting at The UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eighty-two patients were enrolled between February 2008 and February 2010. Two patients withdrew consent and 80 patients were randomized; 40 to the Arm A and 40 to the Arm B.

Reporting Groups
  Description
Group A: Single Dose As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
Group B: Daily Dose Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily

Participant Flow:   Overall Study
    Group A: Single Dose     Group B: Daily Dose  
STARTED     40     40  
COMPLETED     40     40  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Group A: Single Dose As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
Group B: Daily Dose Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
Total Total of all reporting groups

Baseline Measures
    Group A: Single Dose     Group B: Daily Dose     Total  
Number of Participants  
[units: participants]
  40     40     80  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 27 to 82 )  
  58  
  ( 27 to 81 )  
  60  
  ( 27 to 82 )  
Gender  
[units: participants]
     
Female     10     10     20  
Male     30     30     60  
Region of Enrollment  
[units: participants]
     
United States     40     40     80  



  Outcome Measures

1.  Primary:   Number of Participants With Plasma Uric Acid (UA) Response   [ Time Frame: First cycle of chemotherapy, up to 5 days ]


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


Results Point of Contact:  
Name/Title: Saroj Vadhan-Raj, MD / Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


Publications of Results:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00628628     History of Changes
Other Study ID Numbers: 2006-0918
Study First Received: February 25, 2008
Results First Received: May 31, 2013
Last Updated: May 31, 2013
Health Authority: United States: Institutional Review Board