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Rasburicase in Patients at Risk for Tumor Lysis Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00628628
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : August 1, 2013
Last Update Posted : August 1, 2013
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tumor Lysis Syndrome
Interventions Drug: As Needed Rasburicase
Drug: Fixed Dose Rasburicase
Enrollment 82
Recruitment Details 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 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.
Arm/Group Title Group A: Single Dose Group B: Daily Dose
Hide Arm/Group Description As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed. Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
Period Title: Overall Study
Started 40 40
Completed 40 40
Not Completed 0 0
Arm/Group Title Group A: Single Dose Group B: Daily Dose Total
Hide Arm/Group Description As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed. Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
62
(27 to 82)
58
(27 to 81)
60
(27 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
10
  25.0%
10
  25.0%
20
  25.0%
Male
30
  75.0%
30
  75.0%
60
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Number of Participants With Plasma Uric Acid (UA) Response
Hide Description Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.
Time Frame First cycle of chemotherapy, up to 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: Single Dose Group B: Daily Dose
Hide Arm/Group Description:
As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
39 34
Time Frame 2 years, 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A: Single Dose Group B: Daily Dose
Hide Arm/Group Description As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed. Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
All-Cause Mortality
Group A: Single Dose Group B: Daily Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group A: Single Dose Group B: Daily Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   2/40 (5.00%) 
Blood and lymphatic system disorders     
Leukemia  1  0/40 (0.00%)  1/40 (2.50%) 
Lymphoma  1  0/40 (0.00%)  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Group A: Single Dose Group B: Daily Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   40/40 (100.00%)   40/40 (100.00%) 
Blood and lymphatic system disorders     
Methemoglobinemia  1  0/40 (0.00%)  1/40 (2.50%) 
Hemolysis  1  1/40 (2.50%)  0/40 (0.00%) 
Hyperuricemia  1  13/40 (32.50%)  11/40 (27.50%) 
Hyperphosphatemia  1  16/40 (40.00%)  12/40 (30.00%) 
Hypocalcemia  1  28/40 (70.00%)  20/40 (50.00%) 
Hyperkalemia  1  1/40 (2.50%)  1/40 (2.50%) 
Metabolism and nutrition disorders     
Clinical tumor lysis syndrome  1  0/40 (0.00%)  3/40 (7.50%) 
Laboratory tumor lysis syndrome  1  14/40 (35.00%)  11/40 (27.50%) 
Renal and urinary disorders     
Increased serum creatinine  1  0/40 (0.00%)  4/40 (10.00%) 
Renal events requiring dialysis  1  1/40 (2.50%)  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Saroj Vadhan-Raj, MD / Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00628628    
Other Study ID Numbers: 2006-0918
First Submitted: February 25, 2008
First Posted: March 5, 2008
Results First Submitted: May 31, 2013
Results First Posted: August 1, 2013
Last Update Posted: August 1, 2013