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JAPANESE
国立保健医療科学院
JRCT ID: jRCT1051240144

Registered date:02/10/2024

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedTumor lysis syndrome, Malignant lymphoma, Acute lymphoblastic leukemia
Date of first enrollment02/10/2024
Target sample size50
Countries of recruitment
Study typeInterventional
Intervention(s)Administer rasburicase as needed

Outcome(s)

Primary OutcomeLaboratory TLS (LTLS) by 7 days after the start of chemotherapy
Secondary OutcomeClinical 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 maximumNot applicable
GenderBoth
Include criteria1.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 criteria1.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

Contact

Public contact
Name Sakuya Matsumoto
Address 7-5-2 Kusunokicho Chuo-ku, Kobe-shi, Hyogo-ken Hyogo Japan 650-0017
Telephone +81-78-382-5111
E-mail samatsu@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name Hironobu Minami
Address 7-5-2 Kusunokicho Chuo-ku, Kobe-shi, Hyogo-ken Hyogo Japan 650-0017
Telephone +81-78-382-5111
E-mail hminami@med.kobe-u.ac.jp
Affiliation Kobe University Hospital