Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome

Launched by M.D. ANDERSON CANCER CENTER · Feb 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called pegloticase to see if it can help lower high levels of uric acid in patients who have tumor lysis syndrome, a condition that can occur after cancer treatment. When cancer cells break down, they release substances like uric acid into the blood, which can lead to serious kidney problems. The goal of the study is to find out if giving pegloticase to cancer patients with high uric acid can improve their condition and protect their kidneys.

To participate in this trial, patients need to be at least 18 years old and must have a high uric acid level of 6 mg/dL or more. They should also be considered stable and expected to live for at least one month based on their doctor’s assessment. Participants will need to provide consent to join the study and should not have certain medical conditions or allergies that would disqualify them. If eligible, patients can expect to receive the investigational medication and be monitored closely by healthcare professionals throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• For inclusion in the study, patients should fulfill the following criteria:
• • 1. Signed informed consent prior to any study specific procedures (patient or caregiver)
• • 2. Male or female 18 years of age or older
• • 3. In the investigator's opinion, expected survival of at least 1 month
• • 4. Deemed stable by the investigator
• • 5. Serum Uric Acid ≥ 6 mg/dL
• • 6. Risk for tumor lysis syndrome based on the MD Anderson TLS risk score
• Exclusion Criteria:
• Patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled:
• • 1. Inability or refusal to give informed consent (patient or caregiver)
• • 2. Subject unwilling to take study medication
• • 3. Known allergy to uricase
• • 4. Pregnant
• • 5. Breastfeeding
• • 6. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
• • 7. Transfusion in last 7 days (as this interferes with G6PD test), with the exception of platelet transfusions.
• • 8. Has received rasburicase during current admission.(Can be considered i24 hours after last Rasburicase administered, current or previous admission)