Status:
ACTIVE_NOT_RECRUITING
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial studies the effect of pegloticase in reducing uric acid levels in patients with hyperuricemia (high blood levels of uric acid) caused by tumor lysis syndrome. Tumor lysis syndrome occurs wh...
Detailed Description
PRIMARY OBJECTIVE: I. To collect preliminary data on the effectiveness of a single dose of pegloticase in lowering serum uric acid levels to less than 6.0 mg/dl within 24 hours in patients with hyper...
Eligibility Criteria
Inclusion
- For inclusion in the study, patients should fulfill the following criteria:
- Signed informed consent prior to any study specific procedures (patient or caregiver)
- Male or female 18 years of age or older
- In the investigator's opinion, expected survival of at least 1 month
- Deemed stable by the investigator
- Serum Uric Acid ≥ 6 mg/dL
- Risk for tumor lysis syndrome based on the MD Anderson TLS risk score
Exclusion
- Patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled:
- Inability or refusal to give informed consent (patient or caregiver)
- Subject unwilling to take study medication
- Known allergy to uricase
- Pregnant
- Breastfeeding
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Transfusion in last 7 days (as this interferes with G6PD test), with the exception of platelet transfusions.
- Has received rasburicase during current admission.(Can be considered i24 hours after last Rasburicase administered, current or previous admission)
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04745910
Start Date
April 5 2022
End Date
July 31 2026
Last Update
December 18 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030