ACTIVE_NOT_RECRUITING

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

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Tumor Lysis Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 when the breakdown products of cancer cells, such as uric acid, enter the blood stream. High levels of uric acid in blood may cause kidney damage and reduce kidney function. The goal of this trial is to learn if pegloticase may lower uric acid levels in blood when given to cancer patients with hyperuricemia caused by tumor lysis syndrome.

Official Title

Effect of Pegloticase on Reduction of Uric Acid in Patients With Tumor Lysis Syndrome: A Pilot Pragmatic Clinical Trial

Quick Facts

Study Start:2022-04-05

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04745910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Principal Investigator

Sreedhar Mandayam, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Sreedhar Mandayam, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-05

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-04-05

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Tumor Lysis Syndrome