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Uric Acid Lowering Agent
Rasburicase for Tumor Lysis Syndrome
Phase 4
Waitlist Available
Led By Sreedhar Mandayam, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High risk for tumor lysis syndrome based on the MD Anderson Tumor Lysis Syndrome (TLS) risk score
Signed informed consent prior to any study specific procedures (patient or caregiver)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of single dose of pegloticase
Awards & highlights
Study Summary
This trial studies if a medication called pegloticase can lower high uric acid levels in blood caused by cancer breakdown products entering the blood, which may damage kidneys.
Eligible Conditions
- Tumor Lysis Syndrome
- Blood Cancers
- Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours of single dose of pegloticase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours of single dose of pegloticase
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Renal function
Time from pegloticase infusion until serum uric acid levels drop to 6 mg/dL
Other outcome measures
Serum uric acid level
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pegloticase)Experimental Treatment2 Interventions
Patients receive pegloticase IV over 120 minutes. Patients whose serum uric acid does not drop below 6 mg/dL within 24 hours receive a second dose of pegloticase IV over 120 minutes on day 2. Patients whose serum uric acid does not drop below 6 mg/dL after two doses of pegloticase receive standard of care rasburicase IV QD for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rasburicase
2011
Completed Phase 4
~320
Pegloticase
2021
Completed Phase 4
~560
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,960 Previous Clinical Trials
1,803,256 Total Patients Enrolled
3 Trials studying Tumor Lysis Syndrome
155 Patients Enrolled for Tumor Lysis Syndrome
Sreedhar Mandayam, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
48 Total Patients Enrolled
Sreedhar MandayamPrincipal InvestigatorM.D. Anderson Cancer Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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