Study of rasburicase administered as needed to prevent the development of tumor lysis syndrome

Study of rasburicase administered as needed to prevent the development of tumor lysis syndrome - SMART study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1051240144

Enrollment

Registered

2024-10-02

Start date

2024-10-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor lysis syndrome, Malignant lymphoma, Acute lymphoblastic leukemia

Interventions

Administer rasburicase as needed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.At least 18 years old and able to provide written informed consent 2.Patient with malignant lymphoma or acute lymphoblastic leukemia who are scheduled to receive standard chemotherapy 3.TLS intermediate or high risk 4.ECOG PS0-2 a:Standard chemotherapy is assumed to be of similar intensity to the regimens listed below, although the exact regimen is not specified. Newly diagnosed:R-CHOP, Pola-RCHP, DA-EPOCH-R, R-hyperCVAD, MA, ALL prephase, PSL with Dasatinib, SMILE, etc Relapse: R-CHASE, R-ESHAP, R-DeVIC, etc

Exclusion criteria

Exclusion criteria: 1.LTLS or CTLS prior to chemotherapy 2.eGFR==8.0 mg/dL, K >= 6.0 mEq/dL, P >= 4.5 mg/dL Definition of CTLS In addition to LTLS, one or more of the following: Decreased renal function (serum creatinine >=1.5 x upper reference limit), arrhythmia or sudden death, seizures b:Measurement of G6PD prior to rasburicase administration is not required. Exclude only those who are known by medical interview c:Treatments not expected to cause TLS, such as oral etoposide, should be excluded. If there is any uncertainty, please consult the study office.

Design outcomes

Primary

Measure	Time frame
Laboratory TLS (LTLS) by 7 days after the start of chemotherapy	—

Secondary

Measure	Time frame
Clinical TLS by 7 days after chemotherapy Number of additional doses of rasburicase Percentage of uric acid levels kept within normal range by 7 days after chemotherapy Incidence of hyperkalemia, hyperphosphatemia and hyperuricemia by 7 days after chemotherapy TLS incidence in the PSL pretreatment group Risk factors for additional rasburicase administration TLS incidence rate by disease TLS incidence rate by TLS risk Adverse events during the study period	—

Measure

Time frame

Clinical TLS by 7 days after chemotherapy Number of additional doses of rasburicase Percentage of uric acid levels kept within normal range by 7 days after chemotherapy Incidence of hyperkalemia, hyperphosphatemia and hyperuricemia by 7 days after chemotherapy TLS incidence in the PSL pretreatment group Risk factors for additional rasburicase administration TLS incidence rate by disease TLS incidence rate by TLS risk Adverse events during the study period

—

Contacts

Public ContactKeiji Kurata

Kobe University Hospital

kkurata@med.kobe-u.ac.jp+81-78-382-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026