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Trial Outcomes & Findings for Rasburicase in Patients at Risk for Tumor Lysis Syndrome (NCT NCT00628628)

NCT ID: NCT00628628

Last Updated: 2013-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

First cycle of chemotherapy, up to 5 days

Results posted on

2013-08-01

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
40
40
Overall Study
COMPLETED
40
40
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rasburicase in Patients at Risk for Tumor Lysis Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group A: Single Dose
n=40 Participants
As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
Group B: Daily Dose
n=40 Participants
Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
Total
n=80 Participants
Total of all reporting groups
Age Continuous
62 years
n=5 Participants
58 years
n=7 Participants
60 years
n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Sex: Female, Male
Male
30 Participants
n=5 Participants
30 Participants
n=7 Participants
60 Participants
n=5 Participants
Region of Enrollment
United States
40 participants
n=5 Participants
40 participants
n=7 Participants
80 participants
n=5 Participants

PRIMARY outcome

Timeframe: First cycle of chemotherapy, up to 5 days

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.

Outcome measures

Outcome measures
Measure
Group A: Single Dose
n=40 Participants
As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
Group B: Daily Dose
n=40 Participants
Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
Number of Participants With Plasma Uric Acid (UA) Response
39 participants
34 participants

Adverse Events

Group A: Single Dose

Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths

Group B: Daily Dose

Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Group A: Single Dose
n=40 participants at risk
As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
Group B: Daily Dose
n=40 participants at risk
Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
Blood and lymphatic system disorders
Leukemia
0.00%
0/40 • 2 years, 1 month
2.5%
1/40 • 2 years, 1 month
Blood and lymphatic system disorders
Lymphoma
0.00%
0/40 • 2 years, 1 month
2.5%
1/40 • 2 years, 1 month

Other adverse events

Other adverse events
Measure
Group A: Single Dose
n=40 participants at risk
As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
Group B: Daily Dose
n=40 participants at risk
Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
Blood and lymphatic system disorders
Methemoglobinemia
0.00%
0/40 • 2 years, 1 month
2.5%
1/40 • 2 years, 1 month
Blood and lymphatic system disorders
Hemolysis
2.5%
1/40 • 2 years, 1 month
0.00%
0/40 • 2 years, 1 month
Metabolism and nutrition disorders
Clinical tumor lysis syndrome
0.00%
0/40 • 2 years, 1 month
7.5%
3/40 • 2 years, 1 month
Metabolism and nutrition disorders
Laboratory tumor lysis syndrome
35.0%
14/40 • 2 years, 1 month
27.5%
11/40 • 2 years, 1 month
Blood and lymphatic system disorders
Hyperuricemia
32.5%
13/40 • 2 years, 1 month
27.5%
11/40 • 2 years, 1 month
Blood and lymphatic system disorders
Hyperphosphatemia
40.0%
16/40 • 2 years, 1 month
30.0%
12/40 • 2 years, 1 month
Blood and lymphatic system disorders
Hypocalcemia
70.0%
28/40 • 2 years, 1 month
50.0%
20/40 • 2 years, 1 month
Blood and lymphatic system disorders
Hyperkalemia
2.5%
1/40 • 2 years, 1 month
2.5%
1/40 • 2 years, 1 month
Renal and urinary disorders
Increased serum creatinine
0.00%
0/40 • 2 years, 1 month
10.0%
4/40 • 2 years, 1 month
Renal and urinary disorders
Renal events requiring dialysis
2.5%
1/40 • 2 years, 1 month
2.5%
1/40 • 2 years, 1 month

Additional Information

Saroj Vadhan-Raj, MD / Professor

The University of Texas (UT) MD Anderson Cancer Center

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place