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

JRCT ID: jRCT1051240144

Registered date:02/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Tumor lysis syndrome, Malignant lymphoma, Acute lymphoblastic leukemia
• Date of first enrollment: 24/10/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Administer rasburicase as needed

Outcome(s)

• Primary Outcome: Laboratory TLS (LTLS) by 7 days after the start of chemotherapy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.At least 18 years old and able to provide written informed consent
2.Untreated malignant lymphoma or acute lymphoblastic leukemia who are scheduled to receive one of the following chemotherapies
(R-)CHOP, Pola-RCHP, DA-EPOCH(-R), DeVIC, (R-)hyperCVAD/MA, ALL prephase, PSL+Dasatinib, GB, RB, A+CHP, VR-CAP, SMILE
3.TLS intermediate or high risk
4.ECOG PS0-2

Exclude criteria

1.LTLS or CTLS prior to chemotherapy
2.eGFR=<30 mL/min/1.73m2
3.Intolerance of adequate hydration due to cardiac dysfunction or fluid retention
4.Patients not expected to survive longer than 3 months
5.Patients previously treated with rasburicase
6.Pregnant patients or breastfeeding patients
7.Patients with known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
8.Patients who are deemed to be inappropriate to participate by physician

a:Definition of LTLS
Abnormality of 2 or more of the following: UA >=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

Related Information

• Primary Sponsor: Minami Hironobu